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

This study is currently recruiting participants.
Verified July 2012 by Cytochroma Inc.
Sponsor:
Information provided by (Responsible Party):
Cytochroma Inc.
ClinicalTrials.gov Identifier:
NCT01651000
First received: July 23, 2012
Last updated: October 11, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Chronic Kidney Disease
Secondary Hyperparathyroidism (SHPT)
Vitamin D Insufficiency
Drug: CTAP101 30 μg capsules
Drug: CTAP101 60 μg capsules
Drug: CTAP101 30 μg sugar pill capsule
Drug: CTAP101 60 μg sugar pill capsules
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Cytochroma Inc.:

Primary Outcome Measures:
  • Changes of at least 30% in plasma iPTH from pretreatment baseline [ Time Frame: Approximately 6 months ] [ Designated as safety issue: No ]

    Primary Objectives:

    The primary objectives of this study are:

    To evaluate the efficacy of CTAP101 Capsules versus placebo in reducing plasma intact parathyroid hormone (iPTH) by at least 30% from pre-treatment baseline


  • Changes in safety and tolerability to CTAP101 capsules [ Time Frame: Approximately 6 months ] [ Designated as safety issue: Yes ]
    To investigate the safety and tolerability of CTAP101 Capsules through changes in adverse events, physical examinations,vital signs, clinical laboratory tests, vital signs, and 12-lead ECGs


Secondary Outcome Measures:
  • Changes in serum total 25D to ≥ 30 ng/ML [ Time Frame: Approximately 6 months ] [ Designated as safety issue: No ]
    To evaluate the efficacy of CTAP101 capsules versus placebo in increasing serum total 25D to ≥ 30 ng/ML

  • Changes in hypercalciuria, hypercalcemia and drug-related hyperphosphatemia. [ Time Frame: Approximately 6 months ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Changes in efficacy and safety based on weight, age, gender, race, dose, CKD stage, SHPT severity, use of Vitamin D supplements, use of Ca supplements, baseline serum total 25D and eGFR [ Time Frame: Approximately 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 210
Study Start Date: September 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CTAP101 30 μg capsules
1 CTAP101 30 μg capsule daily at bedtime
Drug: CTAP101 30 μg capsules
Subjects will take 1 capsule (CTAP101 30 μg or matching placebo)daily at bedtime for 12 weeks. After 12 weeks, the dose may be increased in a blinded fashion based on dose titration criterion.
Active Comparator: CTAP101 60 μg capsules
2 CTAP101 30 μg capsules daily at bedtime
Drug: CTAP101 60 μg capsules
Subjects will take 1 capsule (CTAP101 30 μg or matching placebo)daily at bedtime for 12 weeks. After 12 weeks, the dose may be increased in a blinded fashion based on dose titration criterion.
Placebo Comparator: CTAP101 30 μg sugar pill capsule
1 CTAP101 sugar pill capsule daily at bedtime
Drug: CTAP101 30 μg sugar pill capsule
Subjects will take 1 capsule (CTAP101 30 μg or matching placebo)daily at bedtime for 12 weeks. After 12 weeks, the dose may be increased in a blinded fashion based on dose titration criterion.
Placebo Comparator: CTAP101 60 μg sugar pill capsules
2 CTAP101 30 μg sugar pill capsules daily at bedtime
Drug: CTAP101 60 μg sugar pill capsules
Subjects will take 1 capsule (CTAP101 30 μg or matching placebo)daily at bedtime for 12 weeks. After 12 weeks, the dose may be increased in a blinded fashion based on dose titration criterion.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01651000

Contacts
Contact: Rose Green, R.Ph. 847-236-7707 ext 204 rose.green@cytochroma.com
Contact: Joel Melnick, MD 847-236-7707 ext 243 joel.melnick@cytochroma.com

Locations
United States, Illinois
Cytochroma Inc. Recruiting
Bannockburn, Illinois, United States, 60015
Contact: Rose Green, R.Ph.    847-236-7707 ext 204    rose.green@cytochroma.com   
Contact: Joel Melnick, MD    847-236-7707 ext 243    joel.melnick@cytochroma.com   
Sponsors and Collaborators
Cytochroma Inc.
  More Information

No publications provided

Responsible Party: Cytochroma Inc.
ClinicalTrials.gov Identifier: NCT01651000     History of Changes
Other Study ID Numbers: CTAP101-CL-3001
Study First Received: July 23, 2012
Last Updated: October 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Cytochroma Inc.:
Parathyroid Diseases
Renal Insufficiency
Kidney Failure, Chronic
Hyperparathyroidism, Secondary
Vitamin D
Hyperparathyroidism
Kidney Diseases
Kidney Failure
Renal Insufficiency, Chronic

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Parathyroid Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency
Contraceptives, Oral
Vitamin D
Ergocalciferols
Vitamins
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Bone Density Conservation Agents
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 16, 2014