Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency

Last updated: January 8, 2025
Sponsor: OPKO IP Holdings II, Inc.
Overall Status: Completed

Phase

3

Condition

Focal Segmental Glomerulosclerosis

Neoplasm Metastasis

Nephropathy

Treatment

CTAP101 30 μg capsules

Sugar pill to CTAP101 30 μg capsules

Clinical Study ID

NCT01704079
CTAP101-CL-3002
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  1. Urinary albumin excretion ≤ 3000 mcg/mg of creatinine

  2. Stage 3 or 4 CKD

  3. Plasma iPTH: ≥ 85 pg/mL and < 500 pg/mL

  4. Serum Ca: ≥ 8.4 mg/dL and < 9.8 mg/dL

  5. Serum P: ≥ 2.0 mg/dL and < 5.0 mg/dL

  6. Serum 25-hydroxyvitamin D: ≥ 10 ng/mL and < 30 ng/mL.

  7. Stable dose of Vitamin D therapy ≤ 1600 IU/day and receiving same dose for at least 2 months

Exclusion

Exclusion Criteria:

  1. History of kidney transplant or parathyroidectomy

  2. Spot urine calcium:creatinine ratio > 0.2 (>200 mg/g Cr)

  3. Current serious illness, such as malignancy, HIV, liver disease, cardiovascularevent or hepatitis

  4. Currently on dialysis

  5. Use of pharmacological dose of ergocalciferol or cholecalciferol (≥ 50,000 IU mcgper month) during the study

Study Design

Total Participants: 216
Treatment Group(s): 2
Primary Treatment: CTAP101 30 μg capsules
Phase: 3
Study Start date:
November 01, 2012
Estimated Completion Date:
September 30, 2014

Study Description

This is a phase 3, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of CTAP101 Capsules administered for 26 weeks to treat SHPT in subjects ≥18 years of age with stage 3 or 4 CKD and vitamin D insufficiency. The study will be conducted at approximately 40 sites within the United States (US). Approximately 550 subjects will be screened to randomize approximately 210 eligible subjects, stratified by CKD stage (approximately 105 subjects in each stage) in a 2:1 ratio to receive either CTAP101 Capsules or matching placebo. An Interactive Voice Response System (IVRS) will provide study treatment group assignments using the computer-generated randomization code provided by the IVRS vendor. Subjects will receive an initial daily dose of 1 capsule (CTAP101 Capsules, 30 µg, or matching placebo) for the first 12 weeks. After l2 weeks (visit 8) and per pre-defined criteria, the dose may be increased in a blinded fashion by the IVRS with oversight by an independent medical monitor.

Connect with a study center

  • OPKO Renal

    Bannockburn, Illinois 60015
    United States

    Site Not Available

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