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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Chronic Kidney Disease, Secondary Hyperparathyroidism, Vitamin D Insufficiency

In brief

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).

Key facts

Study ID

NCT01219855

Run by

OPKO Health, Inc.

People needed

78

Starts

2010-10-01

Expected to finish

2011-11-01

Last updated by the study team

2016-08-25

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• OPKO Health, Inc — Bannockburn, Illinois, United States

Full record on ClinicalTrials.gov

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