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

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ClinicalTrials.gov Identifier: NCT01651000
Recruitment Status : Completed
First Posted : July 26, 2012
Results First Posted : August 17, 2016
Last Update Posted : December 18, 2019
Sponsor:
Information provided by (Responsible Party):
OPKO Health, Inc. ( OPKO IP Holdings II, Inc. )

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Hyperparathyroidism, Secondary Vitamin D Deficiency Drug: CTAP101 30 μg capsules Other: Sugar pill to CTAP101 30 μg capsules Phase 3

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 213 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : September 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones Vitamin D
Drug Information available for: Calcifediol

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: CTAP101 30 μg capsules
1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.
 Drug: CTAP101 30 μg capsules
CTAP101 30 μg capsule taken daily at bedtime.
Other Name: Calcifediol

Other: Sugar pill to CTAP101 30 μg capsules
Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
Other Name: Placebo
Placebo Comparator: Sugar pill to CTAP101 30 μg capsule
1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.
 Other: Sugar pill to CTAP101 30 μg capsules
Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
Other Name: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants in the Intent to Treat Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline Values [ Time Frame: Approximately 6 months ]
    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.


Secondary Outcome Measures :
  1. Number of Participants in the Per Protocol Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline Values [ Time Frame: Approximately 6 months ]
    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.

  2. Subjects in the Intent to Treat Population With Normal Serum Total 25-hydroxyvitamin D [ Time Frame: Approximately 6 months ]
    Subjects in the Intent to Treat Population with normal serum total 25-hydroxyvitamin D (>/= 30 ng/dL)

  3. Subjects in the Per Protocol Population With Normal Serum Total 25-hydroxyvitamin D [ Time Frame: Approximately 6 months ]
    Subjects in the Per Protocol Population with normal serum total 25-hydroxyvitamin D (>/= 30 ng/mL)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01651000


Locations
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United States, Illinois
OPKO Renal
Bannockburn, Illinois, United States, 60015
Sponsors and Collaborators
OPKO IP Holdings II, Inc.
Investigators
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Study Director: Joel Melnick, MD Opko Renal
More Information
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Responsible Party: OPKO IP Holdings II, Inc.
ClinicalTrials.gov Identifier: NCT01651000    
Other Study ID Numbers: CTAP101-CL-3001
First Posted: July 26, 2012    Key Record Dates
Results First Posted: August 17, 2016
Last Update Posted: December 18, 2019
Last Verified: December 2019
Keywords provided by OPKO Health, Inc. ( OPKO IP Holdings II, Inc. ):
Parathyroid Diseases
Renal Insufficiency
Kidney Failure, Chronic
Hyperparathyroidism, Secondary
Vitamin D
 Hyperparathyroidism
Kidney Diseases
Kidney Failure
Renal Insufficiency, Chronic
Additional relevant MeSH terms:
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Neoplasm Metastasis
Kidney Diseases
Renal Insufficiency, Chronic
Vitamin D Deficiency
Hyperparathyroidism
Hyperparathyroidism, Secondary
Urologic Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Renal Insufficiency
Avitaminosis
 Deficiency Diseases
Malnutrition
Nutrition Disorders
Parathyroid Diseases
Endocrine System Diseases
Calcifediol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents