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

OPKO Health

Status and phase: Completed; Phase 3; Phase 2

Conditions: Chronic Kidney Disease; Vitamin D Insufficiency; Secondary Hyperparathyroidism

Treatments: Drug: Cohort 1 Matching Sugar Capsule; Drug: Cohort 2 Matching Sugar Capsule; Drug: Cohort 1 CTAP101 Capsules- 60µg; Drug: Cohort 2 CTAP101 Capsules - 30µg; Drug: Cohort 1 CTAP101 Capsules - 90µg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01219855

CTAP101-CL-2008

Details and patient eligibility

About

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).

Enrollment: 78 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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78 participants in 5 patient groups, including a placebo group

Cohort 1: CTAP101 Capsules 60µg

Experimental group

Treatment:

Drug: Cohort 1 CTAP101 Capsules- 60µg

Cohort 1: CTAP101 Capsules 90µg

Experimental group

Treatment:

Drug: Cohort 1 CTAP101 Capsules - 90µg

Cohort 1: Sugar Capsule

Placebo Comparator group

Treatment:

Drug: Cohort 1 Matching Sugar Capsule

Cohort 2: CTAP101 Capsules 30µg

Experimental group

Treatment:

Drug: Cohort 2 CTAP101 Capsules - 30µg

Cohort 2: Sugar Capsule

Placebo Comparator group

Treatment:

Drug: Cohort 2 Matching Sugar Capsule