TerminatedPhase 3

Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary Hyperparathyroidism

Stopped: FDA changed the post-marketing requirement necessitating a new study design and protocol.

United States2 participantsStarted 2023-01-31

Plain-language summary

This is a phase 3, multi-center, randomized, double-blind, placebo-controlled study in children with stage 3-4 chronic kidney disease (CKD), secondary hyperparathyroidism (SHPT) and vitamin D insufficiency.

Who can participate

Age range8 Years – 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

✓. Cohort 1: Be 12 to \<18 years of age and have a body weight of ≥40 kg; Cohort 2: be 8 to \<12 years of age and have a body weight of ≥20 kg.
✓. Be diagnosed with stage 3 to 4 CKD at least six months prior to the screening visit, and have an eGFR of ≥15 to \<60 mL/min/1.73m2 at screening.
✓. Be without any disease state or physical condition that might impair evaluation of safety or which, in the investigator's opinion, would interfere with study participation, including:
✓. Serum albumin ≤ 3.0 g/dL;
✓. Serum transaminase (ALT or SGPT, AST or SGOT) \> 2.5 times the upper limit of normal at screening; and,
✓. Urinary albumin excretion of \>3000 mcg/mg creatinine.
✓. Exhibit during the initial or, if necessary, a screening visit after washout:
✓. Plasma iPTH \>100 pg/mL (stage 3 CKD) or \>160 pg/mL (stage 4 CKD)

Exclusion criteria

✕. History of or planned kidney transplant or parathyroidectomy.
✕. History (prior three months) of serum calcium ≥9.8 mg/dL.
✕. Use of bisphosphonate therapy (denosumab) within six months prior to enrollment.
✕. Known previous or concomitant serious illness or medical condition, such as malignancy, human immunodeficiency virus, significant gastrointestinal or hepatic disease or cardiovascular event or hepatitis, or physical condition that in the opinion of the investigator may worsen and/or interfere with participation in the study.

What they're measuring

Numbers of Subjects Who Attained Mean Decrease in Plasma iPTH of 30% From Baseline

Timeframe: 26 weeks

Safety and Tolerability

Timeframe: 26 weeks

Pharmacokinetic

Timeframe: 26 weeks

Trial details

NCT IDNCT05543928

SponsorOPKO Health, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-19

Results submitted2025-07-08

View on ClinicalTrials.gov More Chronic Kidney Disease stage3 trials

Who can participate

Age range8 Years – 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

✓. Cohort 1: Be 12 to \<18 years of age and have a body weight of ≥40 kg; Cohort 2: be 8 to \<12 years of age and have a body weight of ≥20 kg.
✓. Be diagnosed with stage 3 to 4 CKD at least six months prior to the screening visit, and have an eGFR of ≥15 to \<60 mL/min/1.73m2 at screening.
✓. Be without any disease state or physical condition that might impair evaluation of safety or which, in the investigator's opinion, would interfere with study participation, including:
✓. Serum albumin ≤ 3.0 g/dL;
✓. Serum transaminase (ALT or SGPT, AST or SGOT) \> 2.5 times the upper limit of normal at screening; and,
✓. Urinary albumin excretion of \>3000 mcg/mg creatinine.
✓. Exhibit during the initial or, if necessary, a screening visit after washout:
✓. Plasma iPTH \>100 pg/mL (stage 3 CKD) or \>160 pg/mL (stage 4 CKD)

Exclusion criteria

✕. History of or planned kidney transplant or parathyroidectomy.
✕. History (prior three months) of serum calcium ≥9.8 mg/dL.
✕. Use of bisphosphonate therapy (denosumab) within six months prior to enrollment.
✕. Known previous or concomitant serious illness or medical condition, such as malignancy, human immunodeficiency virus, significant gastrointestinal or hepatic disease or cardiovascular event or hepatitis, or physical condition that in the opinion of the investigator may worsen and/or interfere with participation in the study.