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

NCT ID: NCT05682326

Last Updated: 2025-11-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-06

Study Completion Date

2025-03-17

Brief Summary

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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.

Detailed Description

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Conditions

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Anaemia

Keywords

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Daprodustat ASCEND-P Anemia Chronic kidney disease Erythropoiesis stimulating agent Dialysis Non-dialysis 214066 212914

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is an open-label single arm trial, where all participants are on active treatment with daprodustat.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Daprodustat

All participants will receive daprodustat for up to 52 weeks.

Group Type EXPERIMENTAL

Daprodustat

Intervention Type DRUG

Daprodustat will be administered up to Week 52.

Interventions

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Daprodustat

Daprodustat will be administered up to Week 52.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

3 Months

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Aichi, , Japan

Site Status

GSK Investigational Site

Saitama, , Japan

Site Status

GSK Investigational Site

Tokyo, , Japan

Site Status

GSK Investigational Site

Yangsan, , South Korea

Site Status

Countries

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Argentina Austria Belgium Canada France Germany Italy Netherlands Poland Spain Turkey (Türkiye) United Kingdom United States Japan South Korea

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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214066

Identifier Type: -

Identifier Source: org_study_id