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

Chronic Kidney Disease Clinical Trial

Official title:

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of CTAP101 Capsules to Treat Secondary Hyperparathyroidism in Subjects With Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01651000
• Other study ID #: CTAP101-CL-3001
• Status: Completed
• Phase: Phase 3
• Start date: September 2012
• Est. completion date: July 2014

Study information

• Verified date: December 2019
• Source: OPKO Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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, cardiovascular event or hepatitis

4. Currently on dialysis

5. Use of pharmacological dose of ergocalciferol or cholecalciferol (= 50,000 IU mcg per month) during the study

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Diseases
• Neoplasm Metastasis
• Renal Insufficiency, Chronic
• Vitamin D Deficiency

Intervention

Drug:
• CTAP101 30 µg capsules
CTAP101 30 µg capsule taken daily at bedtime.

Other:
• Sugar pill to CTAP101 30 µg capsules
Sugar pill capsule (placebo to CTAP101 30 µg capsule) taken daily at bedtime.

Locations

Country	Name	City	State
United States	OPKO Renal	Bannockburn	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
OPKO IP Holdings II, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants in the Intent to Treat Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of =30% From Pre-treatment Baseline Values	Number of subjects in the intent to treat population attaining a mean decrease in plasma intact parathyroid hormone (iPTH) of =30% from pre-treatment baseline in the efficacy assessment phase (EAP), referred to as responders.	Approximately 6 months
Secondary	Number of Participants in the Per Protocol Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of =30% From Pre-treatment Baseline Values	Number of subjects in the per protocol population attaining a mean decrease in plasma intact parathyroid hormone (iPTH) of =30% from pre-treatment baseline in the efficacy assessment phase (EAP), referred to as responders.	Approximately 6 months
Secondary	Subjects in the Intent to Treat Population With Normal Serum Total 25-hydroxyvitamin D	Subjects in the Intent to Treat Population with normal serum total 25-hydroxyvitamin D (>/= 30 ng/dL)	Approximately 6 months
Secondary	Subjects in the Per Protocol Population With Normal Serum Total 25-hydroxyvitamin D	Subjects in the Per Protocol Population with normal serum total 25-hydroxyvitamin D (>/= 30 ng/mL)	Approximately 6 months