Daprodustat for Pediatric Anemia

(ASCEND-P Trial)

Recruiting at 65 trial locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: GlaxoSmithKline

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Eligibility Criteria

This trial is for children and adolescents aged 3 months to under 18 years with anemia due to chronic kidney disease (CKD) stages 3-5, not on dialysis, or those on dialysis. Participants must have specific hemoglobin levels depending on their treatment history with erythropoiesis stimulating agents.

Inclusion Criteria

I have anemia due to chronic kidney disease and meet the specified hemoglobin levels.

Written informed consent or assent as appropriate

I am between 3 months and 18 years old.

Exclusion Criteria

I have not had any bleeding in my stomach or intestines in the last month.

Transferrin saturation (TSAT) < 20 percent (%), or Ferritin <25 nanogram (ng)/milliliter (mL)

I have received a kidney transplant and it is working well.

Treatment Details

Interventions

• Daprodustat (HIF-PH Inhibitor)

Trial Overview The study tests Daprodustat's effects over a year in managing anemia in young patients with CKD, both undergoing and not undergoing dialysis. It will measure how the body processes the drug, its safety, and its impact on hemoglobin levels across different age groups.

Participant Groups

Group I: Daprodustat Experimental Treatment 1 Intervention

All participants will receive daprodustat for up to 52 weeks.

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School