Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Neoplasms

Symptoms and General Pathology

Gland and Hormone Related Diseases

Rare Diseases

Kidney Diseases

Neoplasm Metastasis

Hyperparathyroidism

Hyperparathyroidism, Secondary

Renal Insufficiency, Chronic

Kidney Failure, Chronic

Renal Insufficiency

Parathyroid Diseases

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Chronic Disease

Disease Attributes

Neoplastic Processes

Endocrine System Diseases

Chronic Graft Versus Host Disease

Bone Density Conservation Agents

Micronutrients

All Drugs and Chemicals

Vitamins

Vitamin D

Cholecalciferol

Parathyroid Hormone

Vitamin D3

Calciferol

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

Cohort 1 CTAP101 Capsules- 60µg

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

Cohort 1 CTAP101 Capsules - 90µg

Placebo capsules given once daily for 42 days.

Cohort 1 Matching Sugar Capsule

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

Cohort 2 CTAP101 Capsules - 30µg

Cohort 2 Matching Sugar Capsule

Joel Melnick, MD

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).

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

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

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) 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.

Mean absolute change from baseline in serum total 25-hydroxyvitamin D to end of treatment (EOT)

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 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 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)

OPKO Health, Inc.

Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.

Cohorts 1,2: Sugar Capsule

Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.

Cohort 2: CTAP101 Capsules 30µg

Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.

Cohort 1: CTAP101 Capsules 60µg

Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.

Cohort 1: CTAP101 Capsules 90µg

Cohort 1: Sugar Capsule

Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.

Cohort 2: Sugar Capsule

Total

Age, Continuous

Sex: Female, Male

Intent to treat population (excludes a single subject randomized to the 90 µg treatment arm who was lost to follow-up prior to receiving study drug)

Douglass Laidlaw, PhD, Vice President, Medical Affairs

Proportion (%) of Subjects With Serum 25-hydroxyvitamin D ≥30 ng/mL (PP).

Mean Percent Change From Baseline in Plasma Intact Parathyroid Hormone (iPTH) to End of Treatment (Per Protocol Population)

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

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

Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 30% at Week 6

The proportion of subjects achieving a ≥20% decrease in plasma iPTH at EOT was greater in the CTAP101 Capsules 60 and 90 μg groups compared to the corresponding placebo group.

Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 20% at Week 6

Overall Study

Calcifediol

Hormones

Calcium

Calcium, Dietary

Trace Elements

CTAP101/Calcifediol Capsules 60 micrograms (mcg) once daily at bedtime, except on Days 1 and 29 when dosing will occur in the morning before breakfast

Immediate-release (IR) calcifediol/266 micrograms (mcg) capsule before breakfast on the mornings of Day 1 and Day 29

Cholecalciferol/Capsules 300,000 International Units (IU) (high-dose) before breakfast on the mornings of Day 1 and Day 29

Paricalcitol/Capsules 1 mcg plus cholecalciferol capsules 800 IU (low-dose) once daily in the morning before breakfast, except on Days 1 and29 when dosing will occur before breakfast

Calcifediol Oral Capsule

Calcifediol Oral Product

Paricalcitol Oral Capsule

An Open-Label, Repeated-Dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of Oral CTAP101 Capsules, Immediate- Release (IR) Calcifediol, High-Dose Cholecalciferol, and Paricalcitol Plus Low-Dose Cholecalciferol in Patients with Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency

Repeated-dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of CTAP101, Immediate-release Calcifediol, High-dose Cholecalciferol, and Paricalcitol Plus Low-dose Cholecalciferol in Patients With Secondary Hyperparathyroidism, Chronic Kidney Disease 3-4 and Vitamin D Insufficiency

An Open-Label, Repeated-Dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of Oral CTAP101 Capsules, Immediate- Release (IR) Calcifediol, High-Dose Cholecalciferol, and Paricalcitol Plus Low-Dose Cholecalciferol in Patients With Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency

This study is descriptive and no primary or secondary efficacy endpoints are defined.

CTAP101/Calcifediol Capsules 60 micrograms (mcg) once daily at bedtime, except on Days 1 and 29 when dosing will occur in the morning before breakfast

Calcifediol Oral Capsule: Capsule, daily

CTAP101

Immediate-release (IR) calcifediol/266 micrograms (mcg) capsule before breakfast on the mornings of Day 1 and Day 29

Calcifediol Oral Product: Capsule, once a month

Immediate-release (IR) Calcifediol

Cholecalciferol/Capsules 300,000 International Units (IU) (high-dose) before breakfast on the mornings of Day 1 and Day 29

Cholecalciferol: Capsule, once a month

Paricalcitol/Capsules 1 mcg plus cholecalciferol capsules 800 IU (low-dose) once daily in the morning before breakfast, except on Days 1 and29 when dosing will occur before breakfast

Cholecalciferol: Capsule, once a month

Paricalcitol Oral Capsule: Capsule, daily

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT)	NCT01219855	Chronic Kidney ... Secondary Hyper... Vitamin D Insuf...	Cohort 1 CTAP10... Cohort 1 CTAP10... Cohort 1 Matchi... Cohort 2 CTAP10... Cohort 2 Matchi...	18 Years - 85 Years	OPKO Health, Inc.
Repeated-dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of CTAP101, Immediate-release Calcifediol, High-dose Cholecalciferol, and Paricalcitol Plus Low-dose Cholecalciferol in Patients With Secondary Hyperparathyroidism, Chronic Kidney Disease 3-4 and Vitamin D Insufficiency	NCT03588884	Secondary Hyper... Vitamin D Insuf... CKD Stage 3 CKD Stage 4	Calcifediol Ora... Calcifediol Ora... Cholecalciferol Paricalcitol Or...	18 Years -	OPKO Health, Inc.
Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT)	NCT01219855	Chronic Kidney ... Secondary Hyper... Vitamin D Insuf...	Cohort 1 CTAP10... Cohort 1 CTAP10... Cohort 1 Matchi... Cohort 2 CTAP10... Cohort 2 Matchi...	18 Years - 85 Years	OPKO Health, Inc.

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