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

NCT01219855 | Completed Phase 2 Results DMC

• 1 other identifier: CTAP101-CL-2008
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Kidney Disease; Secondary Hyperparathyroidism; Vitamin D Insufficiency

Keywords

Parathyroid Diseases; Renal Insufficiency; Kidney Failure, Chronic; Hyperparathyroidism, Secondary; Vitamin D; Hyperparathyroidism; Kidney Diseases; Kidney Failure; Renal Insufficiency, Chronic

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Change From Baseline in Serum 25-hydroxyvitamin D at Week 6

  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

  Baseline to End of Treatment (6 weeks)

• 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 Reduction of Intact Parathyroid Hormone (iPTH) of at Least 20% at Week 6

  Baseline to End of Treatment (6 weeks)

Study Arms (5)

Cohort 1: CTAP101 Capsules 60µg

EXPERIMENTAL

Drug: Cohort 1 CTAP101 Capsules- 60µg

Cohort 1: CTAP101 Capsules 90µg

EXPERIMENTAL

Drug: Cohort 1 CTAP101 Capsules - 90µg

Cohort 1: Sugar Capsule

PLACEBO COMPARATOR

Drug: Cohort 1 Matching Sugar Capsule

Cohort 2: CTAP101 Capsules 30µg

EXPERIMENTAL

Drug: Cohort 2 CTAP101 Capsules - 30µg

Cohort 2: Sugar Capsule

PLACEBO COMPARATOR

Drug: Cohort 2 Matching Sugar Capsule

Interventions

Cohort 1 CTAP101 Capsules- 60µg DRUG

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

Cohort 1: CTAP101 Capsules 60µg

Cohort 1 CTAP101 Capsules - 90µg DRUG

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

Cohort 1: CTAP101 Capsules 90µg

Cohort 1 Matching Sugar Capsule DRUG

Placebo capsules given once daily for 42 days.

Cohort 1: Sugar Capsule

Cohort 2 CTAP101 Capsules - 30µg DRUG

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

Cohort 2: CTAP101 Capsules 30µg

Cohort 2 Matching Sugar Capsule DRUG

Placebo capsules given once daily for 42 days.

Cohort 2: Sugar Capsule

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• OPKO Health, Inc.: lead

Study Sites (1)

OPKO Health, Inc

Bannockburn, Illinois, 60015, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperparathyroidism, Secondary; Parathyroid Diseases; Renal Insufficiency; Kidney Failure, Chronic; Hyperparathyroidism; Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Endocrine System Diseases

Results Point of Contact

• Title: Douglass Laidlaw, PhD, Vice President, Medical Affairs
• Organization: OPKO Health, Inc.

dlaidlaw@opko.com

305-575-4172

Study Officials

• Joel Melnick, MD

  OPKO Health, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2010
• First Posted: October 13, 2010
• Study Start: October 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: August 25, 2016
• Results First Posted: August 25, 2016

Record last verified: 2014-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)