SuspendedPhase 3

Study to Evaluate the Safety and Tolerability of Ferric Citrate in Children With Hyperphosphatemia Related to Chronic Kidney Disease

Stopped: Sponsor decision

United States45 participantsStarted 2022-06-16

Plain-language summary

This study will be conducted to assess the safety and tolerability of ferric citrate in pediatric participants with hyperphosphatemia related to chronic kidney disease (CKD).

Who can participate

Age range6 Years – 16 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

✓. Hemodialysis adequacy: single-pool Kt/V ≥1.2 for at least 1 hemodialysis session within 2 months.
✓. Peritoneal dialysis: At least 1Kt/V reading ≥1.8 within 4 months.

What they're measuring

Number of participants with serious and non-serious treatment-emergent adverse events (TEAEs) including gastrointestinal (GI) AEs of special interest

Timeframe: up to Week 40

Number of participants with clinically significant laboratory abnormalities or changes in laboratory results

Timeframe: up to Week 40

Number of participants with TEAEs leading to the discontinuation of ferric citrate

Timeframe: up to Week 40

Trial details

NCT IDNCT04523727

SponsorKeryx Biopharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12

View on ClinicalTrials.gov More Hyperphosphatemia Related to Chronic Kidney Disease trials