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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-11-30

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).

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Detailed Description

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Conditions

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Chronic Kidney Disease Secondary Hyperparathyroidism Vitamin D Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Cohort 1: CTAP101 Capsules 60µg

Group Type EXPERIMENTAL

Cohort 1 CTAP101 Capsules- 60µg

Intervention Type DRUG

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

Cohort 1: CTAP101 Capsules 90µg

Group Type EXPERIMENTAL

Cohort 1 CTAP101 Capsules - 90µg

Intervention Type DRUG

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

Cohort 1: Sugar Capsule

Group Type PLACEBO_COMPARATOR

Cohort 1 Matching Sugar Capsule

Intervention Type DRUG

Placebo capsules given once daily for 42 days.

Cohort 2: CTAP101 Capsules 30µg

Group Type EXPERIMENTAL

Cohort 2 CTAP101 Capsules - 30µg

Intervention Type DRUG

30µg of CTAP101 capsules given once daily for 42 days.

Cohort 2: Sugar Capsule

Group Type PLACEBO_COMPARATOR

Cohort 2 Matching Sugar Capsule

Intervention Type DRUG

Placebo capsules given once daily for 42 days.

Interventions

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Cohort 1 CTAP101 Capsules- 60µg

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

Intervention Type DRUG

Cohort 1 CTAP101 Capsules - 90µg

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

Intervention Type DRUG

Cohort 1 Matching Sugar Capsule

Placebo capsules given once daily for 42 days.

Intervention Type DRUG

Cohort 2 CTAP101 Capsules - 30µg

30µg of CTAP101 capsules given once daily for 42 days.

Intervention Type DRUG

Cohort 2 Matching Sugar Capsule

Placebo capsules given once daily for 42 days.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No