Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT)

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Chronic Kidney Disease, Secondary Hyperparathyroidism, Vitamin D Insufficiency

Intervention / Treatment
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* Drug: Cohort 1 CTAP101 Capsules- 60µg
* Drug: Cohort 1 CTAP101 Capsules - 90µg
* Drug: Cohort 1 Matching Sugar Capsule
* Drug: Cohort 2 CTAP101 Capsules - 30µg
* Drug: Cohort 2 Matching Sugar Capsule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: CTAP101 Capsules 60µg<br> | Drug: Cohort 1 CTAP101 Capsules- 60µg<br>* 60µg of CTAP101 capsules given once daily for 42 days.<br>|
| Experimental: Cohort 1: CTAP101 Capsules 90µg<br> | Drug: Cohort 1 CTAP101 Capsules - 90µg<br>* 90µg of CTAP101 capsules given once daily for 42 days.<br>|
| Placebo Comparator: Cohort 1: Sugar Capsule<br> | Drug: Cohort 1 Matching Sugar Capsule<br>* Placebo capsules given once daily for 42 days.<br>|
| Experimental: Cohort 2: CTAP101 Capsules 30µg<br> | Drug: Cohort 2 CTAP101 Capsules - 30µg<br>* 30µg of CTAP101 capsules given once daily for 42 days.<br>|
| Placebo Comparator: Cohort 2: Sugar Capsule<br> | Drug: Cohort 2 Matching Sugar Capsule<br>* Placebo capsules given once daily for 42 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 weeks | 
| 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. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Baseline to End of Treatment (6 weeks) | 
| 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. | Baseline to End of Treatment (6 weeks) | 
| 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) | Baseline to End of Treatment (6 weeks) | 
| 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) | Baseline to End of Treatment (6 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parathyroid Diseases, Renal Insufficiency, Kidney Failure, Chronic, Hyperparathyroidism, Secondary, Vitamin D, Hyperparathyroidism, Kidney Diseases, Kidney Failure, Renal Insufficiency, Chronic