CompletedPhase 3

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

Japan, South Korea4 participantsStarted 2023-09-06

Plain-language 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.

Who can participate

Age range3 Months – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: Up to 56 weeks

Number of Participants With Adverse Event of Special Interests (AESIs)

Timeframe: Up to 56 weeks

Number of Participants With AEs Leading to Study Intervention Discontinuation

Timeframe: Up to 52 weeks

Trial details

NCT IDNCT05682326

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-18

Results submitted2025-09-17

View on ClinicalTrials.gov More Anaemia trials

Plain-language summary

Who can participate

Age range3 Months – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: Up to 56 weeks

Number of Participants With Adverse Event of Special Interests (AESIs)

Timeframe: Up to 56 weeks

Number of Participants With AEs Leading to Study Intervention Discontinuation

Timeframe: Up to 52 weeks