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

A Randomized, Double Blind, Placebo-Controlled, Repeat Dose, Safety, Efficacy and Pharmacokinetic/Pharmacodynamic Study of CTAP101 Capsules in Subjects With Chronic Kidney Disease, Vitamin D Insufficiency and Secondary Hyperparathyroidism

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 Overview

• Status: Completed
• Conditions: Chronic Kidney Disease; Secondary Hyperparathyroidism; Vitamin D Insufficiency
• Intervention / Treatment: Drug: Cohort 1 CTAP101 Capsules- 60µg; Drug: Cohort 1 CTAP101 Capsules - 90µg; Drug: Cohort 1 Matching Sugar Capsule; Drug: Cohort 2 CTAP101 Capsules - 30µg; Drug: Cohort 2 Matching Sugar Capsule

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Bannockburn, Illinois, United States, 60015
      • OPKO Health, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cohort 1: CTAP101 Capsules 60µg	Drug: Cohort 1 CTAP101 Capsules- 60µg; 60µg of CTAP101 capsules given once daily for 42 days.
EXPERIMENTAL: Cohort 1: CTAP101 Capsules 90µg	Drug: Cohort 1 CTAP101 Capsules - 90µg; 90µg of CTAP101 capsules given once daily for 42 days.
PLACEBO_COMPARATOR: Cohort 1: Sugar Capsule	Drug: Cohort 1 Matching Sugar Capsule; Placebo capsules given once daily for 42 days.
EXPERIMENTAL: Cohort 2: CTAP101 Capsules 30µg	Drug: Cohort 2 CTAP101 Capsules - 30µg; 30µg of CTAP101 capsules given once daily for 42 days.
PLACEBO_COMPARATOR: Cohort 2: Sugar Capsule	Drug: Cohort 2 Matching Sugar Capsule; Placebo capsules given once daily for 42 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	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)	Baseline to End of Treatment (6 weeks)
Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 20% at Week 6	Proportion of subjects with at least 20% reduction in plasma intact parathyroid hormone (iPTH) and/or mean iPTH reduction to 70 pg/mL or less at End of Treatment (EOT)	Baseline to End of Treatment (6 weeks)

Collaborators and Investigators

• Sponsor: OPKO Health, Inc.
• Investigators: Study Director: Joel Melnick, MD, OPKO Health, Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (ACTUAL): November 1, 2011
• Study Completion (ACTUAL): November 1, 2011

Study Registration Dates

• First Submitted: October 11, 2010
• First Submitted That Met QC Criteria: October 12, 2010
• First Posted (ESTIMATE): October 13, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): August 25, 2016
• Last Update Submitted That Met QC Criteria: August 24, 2016
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Vitamin D; Kidney Failure, Chronic; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Kidney Failure; Parathyroid Diseases; Hyperparathyroidism, Secondary; Hyperparathyroidism
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urologic Diseases; Endocrine System Diseases; Renal Insufficiency; Parathyroid Diseases; Neoplastic Processes; Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Neoplasm Metastasis; Hyperparathyroidism, Secondary
• Other Study ID Numbers: CTAP101-CL-2008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO