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

NCT01219855 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2016-08-25

Study results available
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Summary

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).

Conditions

Interventions

DRUG

Cohort 1 CTAP101 Capsules- 60µg

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

DRUG

Cohort 1 CTAP101 Capsules - 90µg

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

DRUG

Cohort 1 Matching Sugar Capsule

Placebo capsules given once daily for 42 days.

DRUG

Cohort 2 CTAP101 Capsules - 30µg

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

DRUG

Cohort 2 Matching Sugar Capsule

Placebo capsules given once daily for 42 days.

Sponsors & Collaborators

  • OPKO Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Joel Melnick, MD · OPKO Health, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01219855 on ClinicalTrials.gov