Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01219855
Recruitment Status : Completed
First Posted : October 13, 2010
Results First Posted : August 25, 2016
Last Update Posted : August 25, 2016
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Secondary Hyperparathyroidism Vitamin D Insufficiency 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 Phase 2 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : October 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Proportion (%) of Subjects With Serum 25-hydroxyvitamin D ≥30 ng/mL (PP). [ Time Frame: 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.

  2. Mean Percent Change From Baseline in Plasma Intact Parathyroid Hormone (iPTH) to End of Treatment (Per Protocol Population) [ Time Frame: 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 :
  1. Change From Baseline in Serum 25-hydroxyvitamin D at Week 6 [ Time Frame: Baseline to End of Treatment (6 weeks) ]
    Mean absolute change from baseline in serum total 25-hydroxyvitamin D to end of treatment (EOT)

  2. Percent Change From Baseline in Serum 25-hydroxyvitamin D at End of Treatment (EOT, Week 6) in the Per Protocol Population [ Time Frame: 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.

  3. Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 30% at Week 6 [ Time Frame: 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)

  4. Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 20% at Week 6 [ Time Frame: 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01219855


Locations
Layout table for location information
United States, Illinois
OPKO Health, Inc
Bannockburn, Illinois, United States, 60015
Sponsors and Collaborators
OPKO Health, Inc.
Investigators
Layout table for investigator information
Study Director: Joel Melnick, MD OPKO Health, Inc.
Layout table for additonal information
Responsible Party: OPKO Health, Inc.
ClinicalTrials.gov Identifier: NCT01219855    
Other Study ID Numbers: CTAP101-CL-2008
First Posted: October 13, 2010    Key Record Dates
Results First Posted: August 25, 2016
Last Update Posted: August 25, 2016
Last Verified: September 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by OPKO Health, Inc.:
Parathyroid Diseases
Renal Insufficiency
Kidney Failure, Chronic
Hyperparathyroidism, Secondary
Vitamin D
Hyperparathyroidism
Kidney Diseases
Kidney Failure
Renal Insufficiency, Chronic
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasm Metastasis
Kidney Diseases
Renal Insufficiency, Chronic
Hyperparathyroidism
Hyperparathyroidism, Secondary
Urologic Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Renal Insufficiency
Parathyroid Diseases
Endocrine System Diseases