A Study to Find Out if ASP5354 Can Clearly Help Show the Ureter During Surgery in People With or Without Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT05999747

Recruitment Status : Recruiting

First Posted : August 21, 2023

Last Update Posted : April 15, 2024

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View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Tracking Information

First Submitted Date ^ICMJE

August 14, 2023

First Posted Date ^ICMJE

August 21, 2023

Last Update Posted Date

April 15, 2024

Actual Study Start Date ^ICMJE

February 28, 2024

Estimated Primary Completion Date

July 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Intra-participant comparison in ureter conspicuity for white light (WL) versus near -infrared fluorescence (NIR F) for participants with normal renal function or mild renal impairment. [ Time Frame: Up to 45 minutes after ASP5354 administration (Day 1) ]

Conspicuity will be scored individually for each illumination mode using the 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)

Original Primary Outcome Measures ^ICMJE

Conspicuity will be scored individually for each illumination mode using the 5-Point Likert Scale, ranging from 1 (least conspicuous) to 5 (most conspicuous)

Change History

Current Secondary Outcome Measures ^ICMJE

Intra-participant comparison of ureter conspicuity scores for WL versus the average of all NIR-F time points for participants with normal renal function or mild renal impairment [ Time Frame: Up to end of surgery (Day1) ]
Conspicuity will be scored individually for each illumination mode using the 5-Point Likert Scale, ranging from1 (None) to 5 (Excellent)
Intra-participant comparison of ureter conspicuity scores for WL timepoint versus the end of surgery score with NIR-F for participants with normal renal function or mild renal impairment [ Time Frame: Up to end of surgery (Day1) ]
Conspicuity will be scored individually for each illumination mode using the 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Quantification of ureter conspicuity for WL and NIR-F illumination modes for all participants [ Time Frame: Up to end of surgery (Day1) ]
Ureter conspicuity will be quantified by image analysis measuring the color contrast when ASP5354 is present in the ureter.
Intra-participant difference in ureter conspicuity for WL versus NIR-F for participants with moderate or severe renal impairment [ Time Frame: Up to 45 minutes after ASP5354 administration (Day 1) ]
Conspicuity will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Intra-participant comparison of ureter conspicuity scores for WL versus the average of all NIR-F scores for participants with moderate or severe renal impairment [ Time Frame: Up to end of surgery (Day1) ]
Conspicuity will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Intra-participant comparison of ureter conspicuity scores for WL versus the end of surgery scores with NIR-F for participants with moderate or severe renal impairment [ Time Frame: Up to end of surgery (Day1) ]
Conspicuity will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Intra-participant difference in ureter conspicuity for WL versus NIR-F for participants in all cohorts [ Time Frame: Up to 45 minutes after ASP5354 administration (Day 1) ]
Conspicuity will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Intra-participant comparison of ureter conspicuity scores for WL versus the average of all NIR-F time points for participants in all cohorts [ Time Frame: Up to end of surgery (Day1) ]
Conspicuity will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Intra-participant comparison of ureter conspicuity scores for WL versus the end of surgery score with NIR-F for participants in all cohorts [ Time Frame: Up to end of surgery (Day1) ]
Conspicuity will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Number of participants with Treatment-emergent adverse events (TEAEs) [ Time Frame: Up to Day 15 ]
Adverse events (AEs) will be coded using MedDRA. An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAE is defined as an AE observed after administration of the study intervention and up to the follow-up period.
Number of participants with serious TEAEs [ Time Frame: Up to Day 15 ]
A Serious Adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or other medically important event. A serious TEAE is defined as an SAE observed after administration of the study intervention and up to the follow-up period.
Number of participants with laboratory value abnormalities and/or AEs [ Time Frame: Up to Day 15 ]
Number of participants with potentially clinically significant laboratory values
Number of participants with vital sign abnormalities and/or AEs [ Time Frame: Up to Day 15 ]
Number of participants potentially clinically significant vital signs
Number of participants with electrocardiogram (ECG) /cardiac monitoring abnormalities and/or AEs [ Time Frame: Up to 2 hours post-surgery (Day 1) ]
Number of participants potentially clinically significant ECGs/cardiac monitoring
Pharmacokinetics (PK) of ASP5354 in plasma: concentration [ Time Frame: Up to 45 minutes after ASP5354 administration (Day 1) ]
Concentration will be recorded from the PK plasma samples collected
PK of ASP5354 in urine: concentration [ Time Frame: Up to end of surgery (Day 1) ]
Concentration will be recorded from the PK urine samples collected
PK of ASP5354 in urine: amount of ASP5354 excreted in urine (Ae) [ Time Frame: Up to end of surgery (Day1) ]
Ae will be recorded from the PK urine samples collected
PK of ASP5354 in urine: percentage of ASP5354 dose excreted into urine (Ae percentage) [ Time Frame: Up to end of surgery (Day 1) ]
Ae percentage will be recorded from the PK urine samples collected
Intra-participant difference in ureter conspicuity for WL versus NIR-F at the first time point for participants with normal renal function or mild renal impairment [ Time Frame: Up to 45 minutes after ASP5354 administration (Day 1) ]
BICR's (blinded independent central review) conspicuity assessment of the ureter will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Intra-participant comparison of ureter conspicuity scores for the WL versus the average of all NIR-F time points for participants with normal renal function or mild renal impairment [ Time Frame: Up to the end of surgery (Day 1) ]
BICR's conspicuity assessment of the ureter when using ASP5354 with NIR-F for the duration of the surgical procedure will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Intra-participant comparison of ureter conspicuity scores for the WL time point versus the end of surgery time point score with NIR-F for adults with normal renal function or mild renal impairment [ Time Frame: Up to the end of surgery (Day 1) ]
BICR's conspicuity assessment of the ureter when using ASP5354 with NIR-F for the duration of the surgical procedure will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Intra-participant difference in ureter conspicuity for WL versus NIR-F for participants with moderate or severe renal impairment [ Time Frame: Up to 45 minutes after ASP5354 administration (Day 1) ]
BICR's conspicuity assessment of the ureter at the first time point will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Ureter conspicuity scores for the WL time point versus the average of all NIR-F time points for participants with moderate or severe renal impairment [ Time Frame: Up to the end of surgery (Day 1) ]
BICR's conspicuity assessment of the ureter when using ASP5354 with NIR-F for the duration of the surgical procedure will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Ureter conspicuity scores for the WL time point versus the end of surgery time point score with NIR F for participants with moderate or severe renal impairment [ Time Frame: Up to the end of surgery (Day 1) ]
BICR's conspicuity assessment of the ureter when using ASP5354 with NIR-F for the duration of the surgical procedure will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Intra-participant difference in ureter conspicuity for WL versus NIR-F for all participants in all cohorts [ Time Frame: Up to 45 minutes after ASP5354 administration (Day 1) ]
BICR's conspicuity assessment of the ureter when using ASP5354 with NIR-F for the duration of the surgical procedure will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Ureter conspicuity scores for the WL versus the average of all NIR-F time points for participants in all cohorts [ Time Frame: Up to 45 minutes after ASP5354 administration (Day 1) ]
BICR's conspicuity assessment of the ureter when using ASP5354 with NIR-F for the duration of the surgical procedure will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Ureter conspicuity scores for the WL versus the average of all NIR-F time points for participants in all cohorts [ Time Frame: Up to the end of surgery (Day 1) ]
BICR's conspicuity assessment of the ureter when using ASP5354 with NIR-F for the duration of the surgical procedure will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Ureter conspicuity scores for the WL versus the end of surgery time point score with NIR F for participants in all cohorts [ Time Frame: Up to the end of surgery (Day 1) ]
BICR's conspicuity assessment of the ureter when using ASP5354 with NIR-F for the duration of the surgical procedure will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Inter-rater reliability between the surgeons and BICR for the WL versus NIR-F for participants with normal renal function or mild renal impairment [ Time Frame: 45 minutes after ASP5354 administration (Day 1) ]
Determine degree of concordance between investigator's intra-operative conspicuity assessment of the ureter and BICR assessment
Inter-rater reliability between the surgeons and BICR for the WL versus the average of all NIR-F time points for participants with normal renal function or mild renal impairment [ Time Frame: Up to the end of surgery (Day 1) ]
Determine degree of concordance between investigator's intra-operative conspicuity assessment of the ureter and BICR assessment
Inter-rater reliability between the surgeons and BICR for the WL versus the end of surgery time point score with NIR-F for participants with normal renal function or mild renal impairment [ Time Frame: Up to the end of surgery (Day 1) ]
Determine degree of concordance between investigator's intra-operative conspicuity assessment of the ureter and BICR assessment

Original Secondary Outcome Measures ^ICMJE

Intra-participant comparison of ureter conspicuity scores for WL versus the average of all NIR-F time points for participants with normal renal function or mild renal impairment [ Time Frame: Up to end of surgery (Day1) ]
Conspicuity will be scored individually for each illumination mode using the 5-Point Likert Scale, ranging from 1 (least conspicuous) to 5 (most conspicuous)
Intra-participant comparison of ureter conspicuity scores for WL timepoint versus the end of surgery score with NIR-F for participants with normal renal function or mild renal impairment [ Time Frame: Up to end of surgery (Day1) ]
Conspicuity will be scored individually for each illumination mode using the 5-Point Likert Scale, ranging from 1 (least conspicuous) to 5 (most conspicuous)
Quantification of ureter conspicuity for WL and NIR-F illumination modes for all participants [ Time Frame: Up to end of surgery (Day1) ]
Ureter conspicuity will be quantified by image analysis measuring the color contrast when ASP5354 is present in the ureter.
Intra-participant difference in ureter conspicuity for WL versus NIR-F for participants with moderate or severe renal impairment [ Time Frame: Up to 45 minutes after ASP5354 administration (Day 1) ]
Conspicuity will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (least conspicuous) to 5 (most conspicuous)
Intra-participant comparison of ureter conspicuity scores for WL versus the average of all NIR-F scores for participants with moderate or severe renal impairment [ Time Frame: Up to end of surgery (Day1) ]
Conspicuity will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (least conspicuous) to 5 (most conspicuous)
Intra-participant comparison of ureter conspicuity scores for WL versus the end of surgery scores with NIR-F for participants with moderate or severe renal impairment [ Time Frame: Up to end of surgery (Day1) ]
Conspicuity will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (least conspicuous) to 5 (most conspicuous)
Intra-participant difference in ureter conspicuity for WL versus NIR-F for participants in all cohorts [ Time Frame: Up to 45 minutes after ASP5354 administration (Day 1) ]
Conspicuity will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (least conspicuous) to 5 (most conspicuous)
Intra-participant comparison of ureter conspicuity scores for WL versus the average of all NIR-F time points for participants in all cohorts [ Time Frame: Up to end of surgery (Day1) ]
Conspicuity will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (least conspicuous) to 5 (most conspicuous)
Intra-participant comparison of ureter conspicuity scores for WL versus the end of surgery score with NIR-F for participants in all cohorts [ Time Frame: Up to end of surgery (Day1) ]
Conspicuity will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (least conspicuous) to 5 (most conspicuous)
Number of participants with Treatment-emergent adverse events (TEAEs) [ Time Frame: Up to Day 15 ]
Adverse events (AEs) will be coded using MedDRA. An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAE is defined as an AE observed after administration of the study intervention and up to the follow-up period.
Number of participants with serious TEAEs [ Time Frame: Up to Day 15 ]
A Serious Adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or other medically important event. A serious TEAE is defined as an SAE observed after administration of the study intervention and up to the follow-up period.
Number of participants with laboratory value abnormalities and/or AEs [ Time Frame: Up to Day 15 ]
Number of participants with potentially clinically significant laboratory values
Number of participants with vital sign abnormalities and/or AEs [ Time Frame: Up to Day 15 ]
Number of participants potentially clinically significant vital signs
Number of participants with electrocardiogram (ECG) /cardiac monitoring abnormalities and/or AEs [ Time Frame: Up to 2 hours post-surgery (Day 1) ]
Number of participants potentially clinically significant ECGs/cardiac monitoring
Pharmacokinetics (PK) of ASP5354 in plasma: concentration [ Time Frame: Up to 45 minutes after ASP5354 administration (Day 1) ]
Concentration will be recorded from the PK plasma samples collected
PK of ASP5354 in urine: concentration [ Time Frame: Up to end of surgery (Day 1) ]
Concentration will be recorded from the PK urine samples collected
PK of ASP5354 in urine: amount of ASP5354 excreted in urine (Ae) [ Time Frame: Up to end of surgery (Day1) ]
Ae will be recorded from the PK urine samples collected
PK of ASP5354 in urine: percentage of ASP5354 dose excreted into urine (Ae percentage) [ Time Frame: Up to end of surgery (Day 1) ]
Ae percentage will be recorded from the PK urine samples collected

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study to Find Out if ASP5354 Can Clearly Help Show the Ureter During Surgery in People With or Without Kidney Disease

Official Title ^ICMJE

A Phase 3, Multicenter, Prospective, Randomized, Open-label Study for Intraoperative Ureter(s) Visualization When Using ASP5354 With Near-infrared Fluorescence (NIR-F) Imaging in Adult Participants Undergoing Minimally Invasive and Open Abdominopelvic Surgeries

Brief Summary

The ureter is the tube that carries urine from the kidneys to the bladder. It is difficult for surgeons to see the ureter during abdominal surgery. This could lead to injuring the ureter which, although rare, could be serious.

This study is about a potential new medical dye, called ASP5354. This dye is injected into the person at the start of surgery and is detected in the ureter. This is done by an imaging machine which has an option called near infrared fluorescence, or NIR-F. Together they show live images of specific parts of the body. In this study, ASP5354 is used with an imaging machine with a NIR-F option to show live images of the ureter during surgery.

People with kidneys that work properly and those with kidney problems can take part in this study. The main goal of the study is to find out how clearly the ureter can be seen with ASP5354 during surgery in people whose kidneys work properly or who have mild kidney problems. To do this, the surgeons will inject ASP5354 into the person having surgery. Then, the surgeons will compare images of the ureter with an imaging machine using normal white light and with the NIR-F option. Imaging using normal white light is the standard way surgeons see the ureter during surgery.

People 18 years or older, with or without kidney disease, who were going to have certain abdominal surgeries may be able to take part.

Everyone taking part will receive ASP5354 during surgery, but how the imaging is done will depend on which group they are in. Before surgery, the people whose kidneys work properly or who have mild kidney problems will be assigned into 1 of 2 groups by chance alone. Images of the ureter will be checked in 1 group using normal white light and the other group using normal white light and NIR-F. People with more severe kidney problems will not be assigned to 1 of 2 groups: all images of the ureter will be checked using normal white light and NIR-F.

At the start of surgery, the surgeon will inject ASP5354 into the person having surgery, then will start recording a video of the surgery. Then, after 30 minutes, the surgeon will record how well the ureter can be seen. This will be done by either using normal white light, or normal white light and NIR-F, depending which group each person having surgery is assigned. For the group to be checked with normal white light and NIR-F, the surgeon will do this check every 30 minutes until the end of surgery. For the group to be checked with normal white light only, the surgeon will only do this check after the first 30 minutes.

During the study, people will visit the study hospital 3 times. The first visit is to check if they can take part in the study. People will be asked about their medical history, have a medical examination, and their vital signs checked (blood pressure and pulse rate). Also, they will have some blood and urine tests. For women this may include a pregnancy test. People will have their surgery at the second visit. This will be within 28 days of their first visit. This includes having some blood and urine tests before, during, and after surgery. Also, they will have a medical examination, an electrocardiogram (ECG) to check their heart rhythm, and have their vital signs checked. After surgery, people will return to the clinic 10 days later for a final check-up. They will be asked if they have had any medical problems. Also, they will have a medical examination, have their vital signs checked, and have blood and urine tests.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Intraoperative Ureter Visualization
Abdominolpelvic Surgery

Intervention ^ICMJE

Drug: pudexacianinium chloride

Intravenous

Other Name: ASP5354

Study Arms ^ICMJE

Experimental: White Light/near-infrared fluorescence - Adults with normal renal function or mild renal impairment
Adult participants with normal renal function or mild renal impairment will receive a single dose of ASP5354

Intervention: Drug: pudexacianinium chloride
Experimental: White Light - Adults with normal renal function or mild renal impairment
Adult participants with normal renal function or mild renal impairment will receive a single dose of ASP5354

Intervention: Drug: pudexacianinium chloride
Experimental: White Light/near-infrared fluorescence - Adults with moderate or severe renal impairment
Adult participants with moderate or severe renal impairment will receive a single dose of ASP5354

Intervention: Drug: pudexacianinium chloride

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Estimated Study Completion Date ^ICMJE

July 31, 2024

Estimated Primary Completion Date

July 31, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Participant is scheduled to undergo minimally invasive or open abdominopelvic surgery that may require ureter identification
Participant has normal renal function or has varying degrees of chronic kidney disease as defined by the National Kidney Foundation and calculated by individual estimated glomerular filtration rate (eGFR) using the modification of diet in renal disease formula
- Adult normal/mild eGFR cohort: eGFR ≥ 60 mL/min
- Adult moderate/severe eGFR cohort: eGFR ≥ 15 to < 60 mL/min
Female participant is not pregnant and at least 1 of the following conditions apply:
- Not a woman of childbearing potential
- Woman of childbearing potential who agrees to follow the contraceptive guidance from the time of informed consent through at least 30 days after study intervention administration.
Female participant must agree not to breastfeed starting at the administration of ASP5354 through 30 days after ASP5354 administration.
Female participant must not donate ova starting at the administration of ASP5354 through 30 days after ASP5354 administration.
Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception through at least 30 days after ASP5354 administration.
Male participant must not donate sperm starting at the administration of ASP5354 through 30 days after ASP5354 administration.
Male participant with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy from the start of ASP5354 administration through 30 days after ASP5354 administration.
Participant agrees not to participate in another interventional study while participating in the present study.

Exclusion Criteria:

Participant has any physical or psychiatric condition, which makes the participant unsuitable for study participation.
Participant is anticipated to require ureteral stenting during surgery.
Participant has an active urinary tract infection requiring antibiotic therapy.
Participant has moderate to severe cardiac disease that limits daily functioning (New York Heart Association Class III to IV) or other medical conditions would impact safety or study compliance.
Participant has any clinically relevant laboratory abnormality that could contraindicate surgery.
Participant has a known or suspected hypersensitivity to ASP5354, indocyanine green (ICG) or any components of the formulation used.
Participant has had previous exposure to ASP5354.
Participant has been administered ICG or other NIR-F imaging agents within 48 hours prior to ASP5354 administration, with the exception of participants who receive ICG for lymphatic mapping before the surgery.
Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.
Participant is on hemodialysis, hemodiafiltration or peritoneal dialysis.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: Astellas Pharma Global Development, Inc.

800-888-7704

astellas.registration@astellas.com

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT05999747

Other Study ID Numbers ^ICMJE

5354-CL-0303

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Plan to Share IPD:	Yes
Plan Description:	Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
Supporting Materials:	Study Protocol
Supporting Materials:	Statistical Analysis Plan (SAP)
Supporting Materials:	Clinical Study Report (CSR)
Time Frame:	Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Access Criteria:	Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
URL:	https://www.clinicalstudydatarequest.com

Current Responsible Party

Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Original Responsible Party

Same as current

Current Study Sponsor ^ICMJE

Astellas Pharma Global Development, Inc.

Original Study Sponsor ^ICMJE

Same as current

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Astellas Pharma Global Development, Inc.

PRS Account

Astellas Pharma Inc

Verification Date

April 2024

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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