This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study for Ureter Visualization, Using ASP5354 in Subjects Undergoing Laparoscopic/Minimally Invasive Colorectal Surgery

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04238481
Recruitment Status : Completed
First Posted : January 23, 2020
Results First Posted : February 13, 2023
Last Update Posted : September 13, 2023
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Laparoscopic/Minimally Invasive Colorectal Surgery
Intervention Drug: Pudexacianinium chloride
Enrollment 13
Recruitment Details Participants undergoing laparoscopic/minimally invasive colorectal surgery in which the need for anatomical visualization of the ureter was anticipated were enrolled into this study.
Pre-assignment Details Eligible participants who met inclusion criteria and none of the exclusion criteria were enrolled. A total of 13 participants were randomized, of which 12 participants received study drug.
Arm/Group Title Pudexacianinium Chloride - Dose Level A Pudexacianinium Chloride - Dose Level B Pudexacianinium Chloride - Dose Level C Pudexacianinium Chloride - Dose Level B - Dose Expansion
Hide Arm/Group Description Participants received single dose of pudexacianinium chloride at dose level A by IV bolus infusion on day 1 once the surgical area of interest is in view. Participants received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of interest is in view. Participants received single dose of pudexacianinium chloride at dose level C by IV bolus infusion on day 1 once the surgical area of interest is in view. Participants who were enrolled in the dose expansion group received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of interest is in view.
Period Title: Overall Study
Started 3 4 3 3
Treated 3 3 3 3
Completed 3 3 3 3
Not Completed 0 1 0 0
Reason Not Completed
Miscellaneous             0             1             0             0
Arm/Group Title Pudexacianinium Chloride - Dose Level A Pudexacianinium Chloride - Dose Level B Pudexacianinium Chloride - Dose Level C Pudexacianinium Chloride - Dose Level B - Dose Expansion Total
Hide Arm/Group Description Participants received single dose of pudexacianinium chloride at dose level A by IV bolus infusion on day 1 once the surgical area of interest is in view. Participants received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of interest is in view. Participants received single dose of pudexacianinium chloride at dose level C by IV bolus infusion on day 1 once the surgical area of interest is in view. Participants who were enrolled in the dose expansion group received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of interest is in view. Total of all reporting groups
Overall Number of Baseline Participants 3 3 3 3 12
Hide Baseline Analysis Population Description
The full analysis set (FAS) consisted of all randomized participants who received pudexacianinium chloride and had at least 1 assessment of ureter visualization during surgery.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 3 participants 3 participants 12 participants
55.3  (2.5) 56.7  (11.6) 38.3  (12.4) 57.3  (5.7) 51.9  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 3 participants 12 participants
Female
3
 100.0%
2
  66.7%
2
  66.7%
3
 100.0%
10
  83.3%
Male
0
   0.0%
1
  33.3%
1
  33.3%
0
   0.0%
2
  16.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 3 participants 12 participants
Hispanic or Latino
1
  33.3%
2
  66.7%
1
  33.3%
0
   0.0%
4
  33.3%
Not Hispanic or Latino
2
  66.7%
1
  33.3%
2
  66.7%
3
 100.0%
8
  66.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 3 participants 12 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
1
   8.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
1
   8.3%
White
2
  66.7%
3
 100.0%
3
 100.0%
2
  66.7%
10
  83.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With Successful Anatomical Visualization of the Index Ureter(s)
Hide Description The anatomical visualization of the index ureter(s) was assessed by the investigator intraoperatively using a binary "Yes or No" question on the ability to visualize the ureter and was assessed as successful, if both 30 minutes after pudexacianinium chloride dosing and at end of surgery the visualization was assessed as positive (Yes)/successful. For imputation of missing values at 30 minutes after pudexacianinium chloride administration, the nearest time points before and after the 30 minutes was considered. If both time points (before and after 30 minutes) were successful, 30 minutes anatomical visualization was imputed as successful. If both time points were not successful, then 30 minutes anatomical visualization was imputed as not successful, and all other cases were not imputed.
Time Frame 30 minutes postdose through end of surgery (on day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Population
Arm/Group Title Pudexacianinium Chloride - Dose Level A Pudexacianinium Chloride - Dose Level B Pudexacianinium Chloride - Dose Level C Pudexacianinium Chloride - Dose Level B - Dose Expansion
Hide Arm/Group Description:
Participants received single dose of pudexacianinium chloride at dose level A by IV bolus infusion on day 1 once the surgical area of interest is in view.
Participants received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of Interest is in view.
Participants received single dose of pudexacianinium chloride at dose level C by IV bolus infusion on day 1 once the surgical area of interest is in view.
Participants who were enrolled in the dose expansion group received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of interest is in view.
Overall Number of Participants Analyzed 3 3 3 3
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
66.7
(9.4 to 99.2)
100.0
(29.2 to 100.0)
100.0
(29.2 to 100.0)
66.7
(9.4 to 99.2)
2.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events
Hide Description An adverse event (AE) was any untoward medical occurrence in a participant administered an investigational product (IP), and which did not necessarily have a causal relationship with the treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP whether or not considered related to the IP. A TEAE was defined as an AE observed after administration of the IP and up to the follow-up period. An AE was considered "serious" if the event: results in death;is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions;results in congenital anomaly, or birth defect;requires inpatient hospitalization (except for planned procedures as allowed per study) or leads to prolongation of hospitalization; Other medically important events.
Time Frame From first dose of study drug until follow-up period (day 10)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set (SAF) consisted of all randomized participants who received pudexacianinium chloride.
Arm/Group Title Pudexacianinium Chloride - Dose Level A Pudexacianinium Chloride - Dose Level B Pudexacianinium Chloride - Dose Level C Pudexacianinium Chloride - Dose Level B - Dose Expansion
Hide Arm/Group Description:
Participants received single dose of pudexacianinium chloride at dose level A by IV bolus infusion on day 1 once the surgical area of interest is in view.
Participants received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of Interest is in view.
Participants received single dose of pudexacianinium chloride at dose level C by IV bolus infusion on day 1 once the surgical area of interest is in view.
Participants who were enrolled in the dose expansion group received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of interest is in view.
Overall Number of Participants Analyzed 3 3 3 3
Measure Type: Number
Unit of Measure: participants
2 2 1 1
3.Secondary Outcome
Title Plasma Concentration of Pudexacianinium Chloride
Hide Description Plasma concentration of pudexacianinium chloride was reported from the blood samples collected. Concentrations below the lower limit of quantification (1 nanogram per milliliter [ng/mL]) are set to zero.
Time Frame Predose, 10, 30, 60, 90, 120 minutes, end of surgery, 180 mins post dose
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic analysis set (PKAS) consisted of all randomized participants who received pudexacianinium chloride and had at least 1 plasma or urine concentration data available with the time of dosing and sampling. Participants with available data at specified time point were included in the analysis.
Arm/Group Title Pudexacianinium Chloride - Dose Level A Pudexacianinium Chloride - Dose Level B Pudexacianinium Chloride - Dose Level C Pudexacianinium Chloride - Dose Level B - Dose Expansion
Hide Arm/Group Description:
Participants received single dose of pudexacianinium chloride at dose level A by IV bolus infusion on day 1 once the surgical area of interest is in view.
Participants received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of Interest is in view.
Participants received single dose of pudexacianinium chloride at dose level C by IV bolus infusion on day 1 once the surgical area of interest is in view.
Participants who were enrolled in the dose expansion group received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of interest is in view.
Overall Number of Participants Analyzed 3 3 3 3
Mean (Standard Deviation)
Unit of Measure: ng/mL
Predose Number Analyzed 3 participants 3 participants 3 participants 3 participants
0  (0) 0  (0) 0  (0) 0  (0)
10 Minutes Number Analyzed 3 participants 3 participants 3 participants 3 participants
48.9  (20.6) 196  (161) 322  (177) 272  (278)
30 Minutes Number Analyzed 3 participants 3 participants 3 participants 2 participants
22.5  (3.30) 58.0  (5.74) 146  (46.1) 81.1  (16.2)
60 Minutes Number Analyzed 1 participants 2 participants 1 participants 0 participants
15.3 38.2  (7.35) 106
90 Minutes Number Analyzed 1 participants 1 participants 0 participants 0 participants
12.7 34.4
120 Minutes Number Analyzed 1 participants 0 participants 0 participants 0 participants
8.37
End of Surgery Number Analyzed 3 participants 3 participants 2 participants 3 participants
14.0  (5.98) 28.0  (1.64) 47.3  (29.8) 51.0  (14.7)
180 Minutes Number Analyzed 0 participants 1 participants 0 participants 1 participants
18.0 41.5
4.Secondary Outcome
Title Urine Concentration of Pudexacianinium Chloride
Hide Description Urine concentration of pudexacianinium chloride was reported from the urine samples collected. Concentrations below the lower limit of quantification (20 ng/mL) are set to zero.
Time Frame Predose, 10, 30, 60, 90 minutes, end of surgery, 180 mins post dose
Hide Outcome Measure Data
Hide Analysis Population Description
PKAS population with available data at specified time point.
Arm/Group Title Pudexacianinium Chloride - Dose Level A Pudexacianinium Chloride - Dose Level B Pudexacianinium Chloride - Dose Level C Pudexacianinium Chloride - Dose Level B - Dose Expansion
Hide Arm/Group Description:
Participants received single dose of pudexacianinium chloride at dose level A by IV bolus infusion on day 1 once the surgical area of interest is in view.
Participants received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of Interest is in view.
Participants received single dose of pudexacianinium chloride at dose level C by IV bolus infusion on day 1 once the surgical area of interest is in view.
Participants who were enrolled in the dose expansion group received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of interest is in view.
Overall Number of Participants Analyzed 3 3 2 3
Mean (Standard Deviation)
Unit of Measure: ng/mL
Predose Number Analyzed 3 participants 3 participants 2 participants 3 participants
0  (0) 0  (0) 0  (0) 0  (0)
10 Minutes Number Analyzed 1 participants 2 participants 0 participants 0 participants
0 695  (983)
30 Minutes Number Analyzed 0 participants 2 participants 0 participants 0 participants
10800  (8620)
60 Minutes Number Analyzed 0 participants 2 participants 0 participants 0 participants
12000  (7420)
90 Minutes Number Analyzed 0 participants 1 participants 0 participants 0 participants
6800
End of Surgery Number Analyzed 2 participants 2 participants 2 participants 0 participants
1960  (955) 4840  (3650) 33800  (636)
180 Minutes Number Analyzed 0 participants 1 participants 0 participants 0 participants
953
5.Secondary Outcome
Title Amount of Pudexacianinium Chloride Excreted in Urine (Ae) During Surgery
Hide Description Amount of pudexacianinium chloride excreted in urine during surgery was reported.
Time Frame During surgery (on day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
PKAS population with available data at specified time point.
Arm/Group Title Pudexacianinium Chloride - Dose Level A Pudexacianinium Chloride - Dose Level B Pudexacianinium Chloride - Dose Level C Pudexacianinium Chloride - Dose Level B - Dose Expansion
Hide Arm/Group Description:
Participants received single dose of pudexacianinium chloride at dose level A by IV bolus infusion on day 1 once the surgical area of interest is in view.
Participants received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of Interest is in view.
Participants received single dose of pudexacianinium chloride at dose level C by IV bolus infusion on day 1 once the surgical area of interest is in view.
Participants who were enrolled in the dose expansion group received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of interest is in view.
Overall Number of Participants Analyzed 3 2 3 1
Mean (Standard Deviation)
Unit of Measure: milligrams (mg)
0.0670  (0.0239) 0.212  (0.0339) 1.19  (0.371) 0.0438
6.Secondary Outcome
Title Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%) During Surgery
Hide Description Percentage of pudexacianinium chloride dose excreted into urine during surgery was reported.
Time Frame During surgery (on day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
PKAS population with available data at specified time point.
Arm/Group Title Pudexacianinium Chloride - Dose Level A Pudexacianinium Chloride - Dose Level B Pudexacianinium Chloride - Dose Level C Pudexacianinium Chloride - Dose Level B - Dose Expansion
Hide Arm/Group Description:
Participants received single dose of pudexacianinium chloride at dose level A by IV bolus infusion on day 1 once the surgical area of interest is in view.
Participants received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of Interest is in view.
Participants received single dose of pudexacianinium chloride at dose level C by IV bolus infusion on day 1 once the surgical area of interest is in view.
Participants who were enrolled in the dose expansion group received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of interest is in view.
Overall Number of Participants Analyzed 3 2 3 1
Mean (Standard Deviation)
Unit of Measure: percentage of drug excreted
22.3  (7.98) 21.2  (3.39) 39.5  (12.4) 4.38
Time Frame From first dose of study drug until follow-up period (day 10)
Adverse Event Reporting Description SAF Population
 
Arm/Group Title Pudexacianinium Chloride - Dose Level A Pudexacianinium Chloride - Dose Level B Pudexacianinium Chloride - Dose Level C Pudexacianinium Chloride - Dose Level B - Dose Expansion
Hide Arm/Group Description Participants received single dose of pudexacianinium chloride at dose level A by IV bolus infusion on day 1 once the surgical area of interest is in view. Participants received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of interest is in view. Participants received single dose pudexacianinium chloride at dose level C by IV bolus infusion on day 1 once the surgical area of interest is in view. Participants who were enrolled in the dose expansion group received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of interest is in view.
All-Cause Mortality
Pudexacianinium Chloride - Dose Level A Pudexacianinium Chloride - Dose Level B Pudexacianinium Chloride - Dose Level C Pudexacianinium Chloride - Dose Level B - Dose Expansion
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)      0/3 (0.00%)      0/3 (0.00%)      0/3 (0.00%)    
Hide Serious Adverse Events
Pudexacianinium Chloride - Dose Level A Pudexacianinium Chloride - Dose Level B Pudexacianinium Chloride - Dose Level C Pudexacianinium Chloride - Dose Level B - Dose Expansion
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/3 (66.67%)      0/3 (0.00%)      0/3 (0.00%)      0/3 (0.00%)    
Blood and lymphatic system disorders         
Blood loss anaemia  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0
Gastrointestinal disorders         
Rectal perforation  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Colon cancer  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0
1
Term from vocabulary, MedDRA v23.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pudexacianinium Chloride - Dose Level A Pudexacianinium Chloride - Dose Level B Pudexacianinium Chloride - Dose Level C Pudexacianinium Chloride - Dose Level B - Dose Expansion
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/3 (33.33%)      2/3 (66.67%)      1/3 (33.33%)      1/3 (33.33%)    
Gastrointestinal disorders         
Abdominal rigidity  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0
Injury, poisoning and procedural complications         
Incision site erythema  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0
Procedural nausea  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0
Procedural pain  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Muscle spasms  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0
Renal and urinary disorders         
Haematuria  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1
Proteinuria  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1
1
Term from vocabulary, MedDRA v23.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Disclosure
Organization: Astellas Pharma Inc
Phone: +81 3-3244-6500 Japanese only
EMail: astellas.resultsdisclosure@astellas.com
Layout table for additonal information
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT04238481    
Other Study ID Numbers: 5354-CL-0201
First Submitted: January 20, 2020
First Posted: January 23, 2020
Results First Submitted: January 18, 2023
Results First Posted: February 13, 2023
Last Update Posted: September 13, 2023