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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01219855
• Other study ID #: CTAP101-CL-2008
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 11, 2010
• Last updated: August 24, 2016
• Start date: October 2010
• Est. completion date: November 2011

Study information

• Verified date: September 2014
• Source: OPKO Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Diseases
• Neoplasm Metastasis
• Renal Insufficiency, Chronic
• Secondary Hyperparathyroidism
• Vitamin D Insufficiency

Intervention

Drug:
• Cohort 1 CTAP101 Capsules- 60µg
60µg of CTAP101 capsules given once daily for 42 days.
• Cohort 1 CTAP101 Capsules - 90µg
90µg of CTAP101 capsules given once daily for 42 days.
• Cohort 1 Matching Sugar Capsule
Placebo capsules given once daily for 42 days.
• Cohort 2 CTAP101 Capsules - 30µg
30µg of CTAP101 capsules given once daily for 42 days.
• Cohort 2 Matching Sugar Capsule
Placebo capsules given once daily for 42 days.

Locations

Country	Name	City	State
United States	OPKO Health, Inc	Bannockburn	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
OPKO Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No