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

Phase 2

Completed

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

• Registration Number: NCT01219855
• Lead Sponsor: OPKO Health, Inc.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-11
• Study First Submitted QC: 2010-10-12
• Study First Posted: 2010-10-13
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2014-09
• Disposition First Submitted: 2014-09-16
• Disposition First Submitted QC: 2014-09-16
• Disposition First Posted: 2014-09-29
• Results First Submitted: 2016-07-08
• Results First Submitted QC: 2016-08-24
• Last Update Submitted: 2016-08-24
• Results First Posted: 2016-08-25
• Last Update Posted: 2016-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1: Sugar Capsule	Cohort 1 Matching Sugar Capsule	-
Cohort 2: CTAP101 Capsules 30µg	Cohort 2 CTAP101 Capsules - 30µg	-
Cohort 2: Sugar Capsule	Cohort 2 Matching Sugar Capsule	-
Cohort 1: CTAP101 Capsules 60µg	Cohort 1 CTAP101 Capsules- 60µg	-
Cohort 1: CTAP101 Capsules 90µg	Cohort 1 CTAP101 Capsules - 90µg	-

Primary Outcome Measures

Name	Time	Method
Proportion (%) of Subjects With Serum 25-hydroxyvitamin D ≥30 ng/mL (PP).	6 weeks	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.
Mean Percent Change From Baseline in Plasma Intact Parathyroid Hormone (iPTH) to End of Treatment (Per Protocol Population)	6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Serum 25-hydroxyvitamin D at Week 6	Baseline to End of Treatment (6 weeks)	Mean absolute change from baseline in serum total 25-hydroxyvitamin D to end of treatment (EOT)
Percent Change From Baseline in Serum 25-hydroxyvitamin D at End of Treatment (EOT, Week 6) in the Per Protocol Population	Baseline to End of Treatment (6 weeks)	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.
Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 30% at Week 6	Baseline to End of Treatment (6 weeks)	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)
Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 20% at Week 6	Baseline to End of Treatment (6 weeks)	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)

Trial Locations

Locations (1)

OPKO Health, Inc; 🇺🇸 Bannockburn, Illinois, United States