Phase 3
N=216
Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency
Chronic Kidney Disease · Hyperparathyroidism, Secondary · Vitamin D Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT01704079 ↗Enrolled (actual)
216
Serious AEs
15.3%
Results posted
Aug 2016
Primary outcome: Primary: Number of Participants in the Intent to Treat Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline — 5; 49 participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CTAP101 30 μg capsules (Drug); Sugar pill to CTAP101 30 μg capsules (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- OPKO IP Holdings II, Inc.
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants in the Intent to Treat Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline |
5; 49 | <0.0001 sig |
| SECONDARY Number of Participants in the Per Protocol Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline |
5; 47 | <0.0001 sig |
| SECONDARY Subjects in the Intent to Treat Population With Normal Serum Total 25-hydroxyvitamin D |
5; 120 | <0.0001 sig |
| SECONDARY Subjects in the Per Protocol Population With Normal Serum Total 25-hydroxyvitamin D |
5; 116 | <0.0001 sig |
Summary
This study will evaluate the efficacy of CTAP101 Capsules versus placebo in reducing intact parathyroid hormone (iPTH) by at least 30% from pretreatment baseline; safety and tolerability of CTAP101 will also be evaluated
Eligibility Criteria
Inclusion Criteria
- Urinary albumin excretion ≤ 3000 mcg/mg of creatinine
- Stage 3 or 4 CKD
- Plasma iPTH: ≥ 85 pg/mL and 0.2 (>200 mg/g Cr)
- Current serious illness, such as malignancy, HIV, liver disease, cardiovascular event or hepatitis
- Currently on dialysis
- Use of pharmacological dose of ergocalciferol or cholecalciferol (≥ 50,000 IU mcg per month) during the study
Data sourced from ClinicalTrials.gov (NCT01704079). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.