Back to resultsSafety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT)
Primary Purpose
Chronic Kidney Disease, Secondary Hyperparathyroidism, Vitamin D Insufficiency
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cohort 1 CTAP101 Capsules- 60µg
Cohort 1 CTAP101 Capsules - 90µg
Cohort 1 Matching Sugar Capsule
Cohort 2 CTAP101 Capsules - 30µg
Cohort 2 Matching Sugar Capsule
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Parathyroid Diseases, Renal Insufficiency, Kidney Failure, Chronic, Hyperparathyroidism, Secondary, Vitamin D, Hyperparathyroidism, Kidney Diseases, Kidney Failure, Renal Insufficiency, Chronic
Eligibility Criteria
Inclusion Criteria:
- Urinary albumin excretion of ≤3000 μg of creatinine
- Stage 3 CKD
- Plasma iPTH: > 70 pg/mL and < 500 pg/mL
- Serum Ca: ≥ 8.4 mg/dL and < 10.0 mg/dL
- Serum P: ≥ 2.0 mg/dL and < 5.0 mg/dL
- Serum 25-hydroxyvitamin D: > 10 ng/mL and < 29 ng/mL.
- Discontinue vitamin D use for duration of study
Exclusion Criteria:
- History of kidney transplant or parathyroidectomy
- Spot urine calcium:creatinine ratio > 0.2
- Current serious illness, such as malignancy, HIV, liver disease, cardiovascular event or hepatitis
- Currently on dialysis
Sites / Locations
- OPKO Health, Inc
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
Cohort 1: CTAP101 Capsules 60µg
Cohort 1: CTAP101 Capsules 90µg
Cohort 1: Sugar Capsule
Cohort 2: CTAP101 Capsules 30µg
Cohort 2: Sugar Capsule
Arm Description
Outcomes
Primary Outcome Measures
Proportion (%) of Subjects With Serum 25-hydroxyvitamin D ≥30 ng/mL (PP).
The proportion of subjects in the per protocol population with serum 25-hydroxyvitamin D ≥30 ng/mL at End-of-Treatment (EOT; Week 6) in Cohorts 1 and 2 (60/90 and 30 μg groups, respectively) were compared to their corresponding placebo groups.
Mean Percent Change From Baseline in Plasma Intact Parathyroid Hormone (iPTH) to End of Treatment (Per Protocol Population)
Mean percent change from baseline in plasma intact parathyroid hormone (iPTH) from baseline to End of Treatment (EOT) in the Per Protocol population. Subjects in Cohorts 1 and 2 (dose regimens 60/90 and 30 mcg, respectively) were compared to their respective placebo groups.
Secondary Outcome Measures
Change From Baseline in Serum 25-hydroxyvitamin D at Week 6
Mean absolute change from baseline in serum total 25-hydroxyvitamin D to end of treatment (EOT)
Percent Change From Baseline in Serum 25-hydroxyvitamin D at End of Treatment (EOT, Week 6) in the Per Protocol Population
Mean percent change from baseline in serum 25-hydroxyvitamin D at End of Treatment (EOT, week 6) in the per protocol population. Subjects in Cohorts 1 and 2 (dose regimens of 60/90 and 30 mcg, respectively) were compared versus their corresponding placebo groups.
Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 30% at Week 6
Proportion of subjects with at least 30% reduction in plasma intact parathyroid hormone (iPTH) and/or mean iPTH reduction to 70 pg/mL or less at End of Treatment (EOT)
Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 20% at Week 6
Proportion of subjects with at least 20% reduction in plasma intact parathyroid hormone (iPTH) and/or mean iPTH reduction to 70 pg/mL or less at End of Treatment (EOT)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01219855
Brief Title
Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT)
Official Title
A Randomized, Double Blind, Placebo-Controlled, Repeat Dose, Safety, Efficacy and Pharmacokinetic/Pharmacodynamic Study of CTAP101 Capsules in Subjects With Chronic Kidney Disease, Vitamin D Insufficiency and Secondary Hyperparathyroidism
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OPKO Health, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will investigate how the levels of a repeat dose of CTAP101 changes in the body over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances (pharmacodynamics, PD) in patients with chronic kidney disease (CKD, vitamin D insufficiency and secondary hyperparathyroidism (SHPT).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Secondary Hyperparathyroidism, Vitamin D Insufficiency
Keywords
Parathyroid Diseases, Renal Insufficiency, Kidney Failure, Chronic, Hyperparathyroidism, Secondary, Vitamin D, Hyperparathyroidism, Kidney Diseases, Kidney Failure, Renal Insufficiency, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1: CTAP101 Capsules 60µg
Arm Type
Experimental
Arm Title
Cohort 1: CTAP101 Capsules 90µg
Arm Type
Experimental
Arm Title
Cohort 1: Sugar Capsule
Arm Type
Placebo Comparator
Arm Title
Cohort 2: CTAP101 Capsules 30µg
Arm Type
Experimental
Arm Title
Cohort 2: Sugar Capsule
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Cohort 1 CTAP101 Capsules- 60µg
Intervention Description
60µg of CTAP101 capsules given once daily for 42 days.
Intervention Type
Drug
Intervention Name(s)
Cohort 1 CTAP101 Capsules - 90µg
Intervention Description
90µg of CTAP101 capsules given once daily for 42 days.
Intervention Type
Drug
Intervention Name(s)
Cohort 1 Matching Sugar Capsule
Intervention Description
Placebo capsules given once daily for 42 days.
Intervention Type
Drug
Intervention Name(s)
Cohort 2 CTAP101 Capsules - 30µg
Intervention Description
30µg of CTAP101 capsules given once daily for 42 days.
Intervention Type
Drug
Intervention Name(s)
Cohort 2 Matching Sugar Capsule
Intervention Description
Placebo capsules given once daily for 42 days.
Primary Outcome Measure Information:
Title
Proportion (%) of Subjects With Serum 25-hydroxyvitamin D ≥30 ng/mL (PP).
Description
The proportion of subjects in the per protocol population with serum 25-hydroxyvitamin D ≥30 ng/mL at End-of-Treatment (EOT; Week 6) in Cohorts 1 and 2 (60/90 and 30 μg groups, respectively) were compared to their corresponding placebo groups.
Time Frame
6 weeks
Title
Mean Percent Change From Baseline in Plasma Intact Parathyroid Hormone (iPTH) to End of Treatment (Per Protocol Population)
Description
Mean percent change from baseline in plasma intact parathyroid hormone (iPTH) from baseline to End of Treatment (EOT) in the Per Protocol population. Subjects in Cohorts 1 and 2 (dose regimens 60/90 and 30 mcg, respectively) were compared to their respective placebo groups.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Serum 25-hydroxyvitamin D at Week 6
Description
Mean absolute change from baseline in serum total 25-hydroxyvitamin D to end of treatment (EOT)
Time Frame
Baseline to End of Treatment (6 weeks)
Title
Percent Change From Baseline in Serum 25-hydroxyvitamin D at End of Treatment (EOT, Week 6) in the Per Protocol Population
Description
Mean percent change from baseline in serum 25-hydroxyvitamin D at End of Treatment (EOT, week 6) in the per protocol population. Subjects in Cohorts 1 and 2 (dose regimens of 60/90 and 30 mcg, respectively) were compared versus their corresponding placebo groups.
Time Frame
Baseline to End of Treatment (6 weeks)
Title
Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 30% at Week 6
Description
Proportion of subjects with at least 30% reduction in plasma intact parathyroid hormone (iPTH) and/or mean iPTH reduction to 70 pg/mL or less at End of Treatment (EOT)
Time Frame
Baseline to End of Treatment (6 weeks)
Title
Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 20% at Week 6
Description
Proportion of subjects with at least 20% reduction in plasma intact parathyroid hormone (iPTH) and/or mean iPTH reduction to 70 pg/mL or less at End of Treatment (EOT)
Time Frame
Baseline to End of Treatment (6 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Urinary albumin excretion of ≤3000 μg of creatinine
Stage 3 CKD
Plasma iPTH: > 70 pg/mL and < 500 pg/mL
Serum Ca: ≥ 8.4 mg/dL and < 10.0 mg/dL
Serum P: ≥ 2.0 mg/dL and < 5.0 mg/dL
Serum 25-hydroxyvitamin D: > 10 ng/mL and < 29 ng/mL.
Discontinue vitamin D use for duration of study
Exclusion Criteria:
History of kidney transplant or parathyroidectomy
Spot urine calcium:creatinine ratio > 0.2
Current serious illness, such as malignancy, HIV, liver disease, cardiovascular event or hepatitis
Currently on dialysis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Melnick, MD
Organizational Affiliation
OPKO Health, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
OPKO Health, Inc
City
Bannockburn
State/Province
Illinois
ZIP/Postal Code
60015
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT)
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