Skip to main content
OpenTrials
Completed

NCT Number: NCT01219855

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperparathyroidism Hyperparathyroidism, Secondary Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Parathyroid Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Secondary Hyperparathyroidism Urogenital Diseases Urologic Diseases Vitamin D Insufficiency

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

OPKO Health, Inc

Bannockburn, Illinois, 60015, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Cohort 1 CTAP101 Capsules- 60µg

Drug

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

Cohort 1 CTAP101 Capsules - 90µg

Drug

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

Cohort 1 Matching Sugar Capsule

Drug

Placebo capsules given once daily for 42 days.

Cohort 2 CTAP101 Capsules - 30µg

Drug

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

Cohort 2 Matching Sugar Capsule

Drug

Placebo capsules given once daily for 42 days.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

OPKO Health, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 13, 2010
Registry last updated
Aug 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.