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

March 26, 2024 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, 1270
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alejandro Balestracci
  • Belgium
      • Bruxelles, Belgium, 1020
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Brigitte Adams
      • Liege, Belgium, 4000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Quentin Bertrand
  • France
      • Montpellier, France, 34090
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Marc Fila
        • Contact:
        • Contact:
      • Toulouse cedex 9, France, 31059
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Stéphane Decramer
        • Contact:
        • Contact:
  • Italy
    • Lombardia
      • Milano, Lombardia, Italy, 20122
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Giovanni Montini
        • Contact:
        • Contact:
  • Japan
      • Aichi, Japan, 466-8650
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yoshimitsu Gotoh
      • Okinawa, Japan, 901-1193
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tomoo Kise
      • Osaka, Japan, 594-1101
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Katsusuke Yamamoto
      • Saitama, Japan, 330-8777
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shuichiro Fujinaga
      • Shiga, Japan, 520-2192
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tomoyuki Sakai
      • Shizuoka, Japan, 420-8660
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hirotsugu Kitayama
      • Tokyo, Japan, 162-8666
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Motoshi Hattori
      • Tokyo, Japan, 157-8535
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Koichi Kamei
      • Tokyo, Japan, 183-8561
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Riku Hamada
  • Korea, Republic of
      • Daegu, Korea, Republic of, 41944
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Min Hyun Cho
      • Gwangju, Korea, Republic of, 501-757
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eunmi Yang
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yo Han Ahn
      • Yangsan Gyeongnam, Korea, Republic of, 50612
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ji Yeon Song
  • Netherlands
      • Rotterdam, Netherlands, 3015 GD
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hub De Jong
  • Spain
      • Esplugues De Llobregat. Barcelona, Spain, 08950
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Álvaro Domingo Madrid Aris
        • Contact:
        • Contact:
      • Sevilla, Spain, 41013
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Francisco De la Cerda Ojeda
        • Contact:
        • Contact:
  • Turkey
      • Ankara, Turkey, 6500
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sevcan Bakkaloglu Ezgu
  • United Kingdom
      • London, United Kingdom, SE1 7EH
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Manish Sinha
      • Manchester, United Kingdom, M13 9WL
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Amrit Kaur
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sahar Fathallah-Shaykh
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Somers
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bradley Warady
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Melissa Muff-Luett
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Oleh Akchurin
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rasheed Gbadegesin
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francisco Flores
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-4318
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Benjamin Laskin
    • Texas
      • Amarillo, Texas, United States, 79106
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tetyana Vasylyeva

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 56 weeks
Number of participants with adverse event of special interests (AESIs)
Time Frame: Up to 56 weeks
All AESI will be collected.
Up to 56 weeks
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.
Up to 52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (Day 1) and up to Week 56
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.
Baseline (Day 1) and up to Week 56
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.
Baseline (Day 1) and up to Week 56
Mean change from baseline in weight
Time Frame: Baseline (Day 1) and up to Week 56
Weight readings in kilogram (kg) will be collected.
Baseline (Day 1) and up to Week 56
Mean change from baseline in height
Time Frame: Baseline (Day 1) and up to Week 56
Height readings in centimeters (cm) will be collected.
Baseline (Day 1) and up to Week 56
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.
Up to Week 56
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.
Baseline (Day 1) and up to Week 56
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.
Up to week 56
Mean daprodustat dose
Time Frame: Up to Week 56
Mean values of daprodustat will be calculated and reported.
Up to Week 56
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.
Up to Week 56
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
Up to Week 56
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.
Up to Week 4
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.
Up to Week 4
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.
Up to Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2023

Primary Completion (Estimated)

July 5, 2030

Study Completion (Estimated)

July 5, 2030

Study Registration Dates

First Submitted

January 4, 2023

First Submitted That Met QC Criteria

January 4, 2023

First Posted (Actual)

January 12, 2023

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 214066

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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/

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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