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

Phase 3CompletedNCT01219855

OPKO Health, Inc.78 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Chronic Kidney Disease Secondary Hyperparathyroidism Vitamin D Insufficiency

Interventions

Cohort 1 CTAP101 Capsules- 60µgDRUG

60µg of CTAP101 capsules given once daily for 42 days.

Cohort 1 CTAP101 Capsules - 90µgDRUG

90µg of CTAP101 capsules given once daily for 42 days.

Cohort 1 Matching Sugar CapsuleDRUG

Placebo capsules given once daily for 42 days.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Urinary albumin excretion of ≤3000 μg of creatinine 2. Stage 3 CKD 3. Plasma iPTH: \> 70 pg/mL and \< 500 pg/mL 4. Serum Ca: ≥ 8.4 mg/dL and \< 10.0 mg/dL 5. Serum P: ≥ 2.0 mg/dL and \< 5.0 mg/dL 6. Serum 25-hydroxyvitamin D: \> 10 ng/mL and \< 29 ng/mL. 7. Discontinue vitamin D use for duration of study Exclusion Criteria: 1. History of kidney transplant or parathyroidectomy 2. Spot urine calcium:creatinine ratio \> 0.2 3. Current serious illness, such as malignancy, HIV, liver disease, cardiovascular event or hepatitis 4. Currently on dialysis

Locations (1)

OPKO Health, Inc

Bannockburn, Illinois, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 6 weeks

Secondary Outcomes

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)

Time frame: 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.

Time frame: 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)

Time frame: Baseline to End of Treatment (6 weeks)

Data from ClinicalTrials.gov

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