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Anemia Studies in CKD: Erythropoiesis Via a Novel PHI Daprodustat - Pediatric (ASCEND-P) (ASCEND-P)

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: NCT05682326
Recruitment Status : Recruiting
First Posted : January 12, 2023
Last Update Posted : March 27, 2024
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief Summary:

This is an international, multicenter trial, evaluating pharmacokinetics (PK) (4 weeks), safety (52 weeks), and hemoglobin (Hgb) response (52 weeks) to daprodustat in children and adolescent participants with anemia associated with chronic kidney disease (CKD) incorporating 2 independent sub-trials (Non dialysis [ND] and Dialysis [D]). This study will enroll participants with anemia associated with CKD, in 2 distinct sub-populations differing only by their CKD stage and dialysis requirement (ND: CKD stage 3 to 5 not yet receiving dialysis and D: CKD stage 5d undergoing peritoneal dialysis [PD] or hemodialysis [HD]).

The maximum duration of the study will be approximately 60 weeks, including Screening period (up to 4 weeks), treatment period (52 weeks), and follow-up period (4 weeks).

Outcome measures are identical for the ND and D sub-trials, but will be separately assessed in each sub- trials, overall and within each age subgroups (12 to less than [<] 18 years, 6 to <12 years, 2 to <6 years, and 3 months to <2 years). Except for PK and dose change, which is within each age group only.


Condition or disease Intervention/treatment Phase
Anaemia Drug: Daprodustat Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is an open-label single arm trial, where all participants are on active treatment with daprodustat.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Integrated Pharmacokinetic and Safety Open-label Basket Trial of Daprodustat for the Treatment of Anemia Associated With Chronic Kidney Disease in Male and Female Children and Adolescents Aged 3 Months to Under 18 Years Requiring or Not Requiring Dialysis
Actual Study Start Date : September 6, 2023
Estimated Primary Completion Date : July 5, 2030
Estimated Study Completion Date : July 5, 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Daprodustat
All participants will receive daprodustat for up to 52 weeks.
 Drug: Daprodustat
Daprodustat will be administered up to Week 52.


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to 56 weeks ]
    All AEs and SAEs will be collected.

  2. Number of participants with adverse event of special interests (AESIs) [ Time Frame: Up to 56 weeks ]
    All AESI will be collected.

  3. Number of participants with AEs leading to study intervention discontinuation [ Time Frame: Up to 52 weeks ]
    All AEs leading to study intervention discontinuation will be collected.


Secondary Outcome Measures :
  1. Number of participants with change from baseline in laboratory safety parameters [ Time Frame: Baseline (Day 1) and up to Week 56 ]
    Number of participants with abnormal laboratory safety parameters will be assessed.

  2. Mean change from baseline in blood pressure (BP) [ Time Frame: Baseline (Day 1) and up to Week 56 ]
    Blood pressure readings in millimeters of mercury (mmHg) will be collected.

  3. Mean change from baseline in heart rate (HR) [ Time Frame: Baseline (Day 1) and up to Week 56 ]
    Heart rate readings in beats per minutes (bpm) will be collected.

  4. Mean change from baseline in weight [ Time Frame: Baseline (Day 1) and up to Week 56 ]
    Weight readings in kilogram (kg) will be collected.

  5. Mean change from baseline in height [ Time Frame: Baseline (Day 1) and up to Week 56 ]
    Height readings in centimeters (cm) will be collected.

  6. Mean Hgb value [ Time Frame: Up to Week 56 ]
    Blood samples will be collected from all participants for measurement of Hgb (grams per deciliter [g/dL]) values.

  7. Mean change from baseline in Hgb values [ Time Frame: Baseline (Day 1) and up to Week 56 ]
    Blood samples will be collected from all participants for measurement of Hgb (g/dL) values.

  8. Number of participants with Hgb values above, below and within the target range (10 to 12 g/dL) [ Time Frame: Up to week 56 ]
    Number of participants with Hgb values above, below, and within the target range (10 to 12g/dL) will be assessed.

  9. Mean daprodustat dose [ Time Frame: Up to Week 56 ]
    Mean values of daprodustat will be calculated and reported.

  10. Number of participants with 0 to 10, or greater than [>] 10 dose adjustments [ Time Frame: Up to Week 56 ]
    Number of participants with 0 to 10, or >10 dose adjustments form the starting dose of dapurodustat will be assessed.

  11. Number of participants assigned to each dose level at each visit [ Time Frame: Up to Week 56 ]
    Number of participants assigned to each dose level of dapurodustat will be assessed

  12. Maximum plasma concentration (Cmax) of daprodustat and its metabolites [ Time Frame: Up to Week 4 ]
    Blood samples will be collected for the plasma concentrations of daprodustat from which PK parameters will be determined.

  13. Area under the curve (AUC) at steady state of daprodustat and its metabolites [ Time Frame: Up to Week 4 ]
    Blood samples will be collected for the plasma concentrations of daprodustat from which PK parameters will be determined.

  14. Plasma concentrations of daprodustat metabolites at pre-dose trough (Ctrough) [ Time Frame: Up to Week 4 ]
    Blood samples will be collected for the plasma concentrations of daprodustat metabolites from which PK parameters will be determined.


Eligibility Criteria
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Ages Eligible for Study:   3 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant must be 3 months to less than (<)18 years of age.
  • Anemia associated with CKD stage 3, 4, 5 (not on dialysis) or who have dialysis-dependent CKD, defined as Hgb 7.0 to 11.0 g/dL (if not using erythropoiesis stimulating agents [ESAs]) or Hgb 9.5 to 12.0 g/dL if using ESAs.
  • Written informed consent or assent as appropriate.

Exclusion Criteria:

  • Kidney transplant recipient with a functioning allograft.
  • Scheduled for elective kidney transplantation within 3 months.
  • Transferrin saturation (TSAT) < 20 percent (%), or Ferritin <25 nanogram (ng)/milliliter (mL).
  • History of bone marrow aplasia or pure red cell aplasia.
  • Active hemolysis.
  • Other causes of anemia.
  • Active gastrointestinal bleeding within the last 4 weeks.
  • Active or previous malignancy within the last 2 years.
  • Acute or chronic infection requiring antimicrobial therapy.
  • History of significant thrombotic or thromboembolic events within the last 8 weeks.
  • Heart failure (HF) New York Heart Association (NYHA) Class IV
  • Uncontrolled hypertension.
  • Alanine aminotransferase (ALT) >2× upper limit of normal (ULN), bilirubin >1.5× ULN (unless bilirubin is fractionated and direct bilirubin <35%), and cirrhosis or current unstable liver or biliary disease.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05682326


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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United States, Alabama
GSK Investigational Site Recruiting
Birmingham, Alabama, United States, 35233
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Sahar Fathallah-Shaykh         
United States, Massachusetts
GSK Investigational Site Recruiting
Boston, Massachusetts, United States, 02115
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Michael Somers         
United States, Missouri
GSK Investigational Site Recruiting
Kansas City, Missouri, United States, 64108
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Bradley Warady         
United States, Nebraska
GSK Investigational Site Recruiting
Omaha, Nebraska, United States, 68114
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Melissa Muff-Luett         
United States, New York
GSK Investigational Site Recruiting
New York, New York, United States, 10021
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Oleh Akchurin         
United States, North Carolina
GSK Investigational Site Recruiting
Durham, North Carolina, United States, 27710
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Rasheed Gbadegesin         
United States, Ohio
GSK Investigational Site Recruiting
Cincinnati, Ohio, United States, 45229
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Francisco Flores         
United States, Pennsylvania
GSK Investigational Site Recruiting
Philadelphia, Pennsylvania, United States, 19104-4318
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Benjamin Laskin         
United States, Texas
GSK Investigational Site Recruiting
Amarillo, Texas, United States, 79106
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Tetyana Vasylyeva         
Argentina
GSK Investigational Site Recruiting
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, 1270
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Alejandro Balestracci         
Belgium
GSK Investigational Site Recruiting
Bruxelles, Belgium, 1020
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Brigitte Adams         
GSK Investigational Site Recruiting
Liege, Belgium, 4000
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Quentin Bertrand         
France
GSK Investigational Site Recruiting
Montpellier, France, 34090
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Marc Fila         
GSK Investigational Site Recruiting
Toulouse cedex 9, France, 31059
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Stéphane Decramer         
Italy
GSK Investigational Site Recruiting
Milano, Lombardia, Italy, 20122
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Giovanni Montini         
Japan
GSK Investigational Site Recruiting
Aichi, Japan, 466-8650
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Yoshimitsu Gotoh         
GSK Investigational Site Recruiting
Okinawa, Japan, 901-1193
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Tomoo Kise         
GSK Investigational Site Recruiting
Osaka, Japan, 594-1101
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Katsusuke Yamamoto         
GSK Investigational Site Recruiting
Saitama, Japan, 330-8777
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Shuichiro Fujinaga         
GSK Investigational Site Recruiting
Shiga, Japan, 520-2192
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Tomoyuki Sakai         
GSK Investigational Site Recruiting
Shizuoka, Japan, 420-8660
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Hirotsugu Kitayama         
GSK Investigational Site Recruiting
Tokyo, Japan, 157-8535
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Koichi Kamei         
GSK Investigational Site Recruiting
Tokyo, Japan, 162-8666
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Motoshi Hattori         
GSK Investigational Site Recruiting
Tokyo, Japan, 183-8561
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Riku Hamada         
Korea, Republic of
GSK Investigational Site Recruiting
Daegu, Korea, Republic of, 41944
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Min Hyun Cho         
GSK Investigational Site Recruiting
Gwangju, Korea, Republic of, 501-757
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Eunmi Yang         
GSK Investigational Site Recruiting
Seoul, Korea, Republic of, 03080
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Yo Han Ahn         
GSK Investigational Site Recruiting
Yangsan Gyeongnam, Korea, Republic of, 50612
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Ji Yeon Song         
Netherlands
GSK Investigational Site Recruiting
Rotterdam, Netherlands, 3015 GD
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Hub De Jong         
Spain
GSK Investigational Site Recruiting
Esplugues De Llobregat. Barcelona, Spain, 08950
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Álvaro Domingo Madrid Aris         
GSK Investigational Site Recruiting
Sevilla, Spain, 41013
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Francisco De la Cerda Ojeda         
Turkey
GSK Investigational Site Recruiting
Ankara, Turkey, 6500
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Sevcan Bakkaloglu Ezgu         
United Kingdom
GSK Investigational Site Recruiting
London, United Kingdom, SE1 7EH
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Manish Sinha         
GSK Investigational Site Recruiting
Manchester, United Kingdom, M13 9WL
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Amrit Kaur         
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT05682326    
Other Study ID Numbers: 214066
First Posted: January 12, 2023    Key Record Dates
Last Update Posted: March 27, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
URL: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Daprodustat
ASCEND-P
Anemia
Chronic kidney disease
Erythropoiesis stimulating agent
 Dialysis
Non-dialysis
214066
212914
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases