Trial record 4 of 75 for:
Open Studies | "Parathyroid Diseases"
Safety and Efficacy of CTAP101 Capsules for Treatment of SHPT and Vitamin D Insufficiency
This study is not yet open for participant recruitment.
Verified October 2012 by Cytochroma Inc.
Sponsor:
Cytochroma Inc.
Information provided by (Responsible Party):
Cytochroma Inc.
ClinicalTrials.gov Identifier:
NCT01704079
First received: October 6, 2012
Last updated: October 11, 2012
Last verified: October 2012
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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: Baseline and 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: Baseline and 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: Baseline and 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: Baseline and 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: Baseline and 6 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 210 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | May 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.
|
Detailed Description:
Approximately 210 stage 3 or 4 CKD subjects with SHPT and vitamin D insufficiency will be randomized to either CTAP101 Capsules or matching placebo for 6 months of treatment.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Urinary albumin excretion ≤ 3000 mcg/mg of creatinine
- Stage 3 or 4 CKD
- Plasma iPTH: ≥ 85 pg/mL and < 500 pg/mL
- Serum Ca: ≥ 8.4 mg/dL and < 9.8 mg/dL
- Serum P: ≥ 2.0 mg/dL and < 5.0 mg/dL
- Serum 25-hydroxyvitamin D: ≥ 10 ng/mL and < 30 ng/mL.
- Stable dose of Vitamin D therapy ≤ 1600 IU/day and receiving same dose for at least 2 months
Exclusion Criteria:
- History of kidney transplant or parathyroidectomy
- Spot urine calcium:creatinine ratio > 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01704079
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. | Not yet 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.
Investigators
| Study Director: | Joel Melnick, MD | Cytochroma Inc. |
More Information
No publications provided
| Responsible Party: | Cytochroma Inc. |
| ClinicalTrials.gov Identifier: | NCT01704079 History of Changes |
| Other Study ID Numbers: | CTAP101-CL-3002 |
| Study First Received: | October 6, 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:
|
Parathyroid Diseases Hyperparathyroidism Hyperparathyroidism, Secondary Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic 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 May 16, 2013