Comparison of I.V. CTAP201 and Doxercalciferol (Hectorol) in Subjects With Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT)

Study Overview
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Brief Summary
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This study will compare CTAP201 with Doxercalciferol in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT), undergoing regular hemodialysis, at different dose strengths. This study will also investigate the levels of CTAP201 in the body over time and determine the safety of CTAP201.

Official Title
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Single-Dose, Two-Period, Open Label, Dose Determination, Randomized, Cross-Over Study of CTAP201 Injection and Doxercalciferol (Hectorol) Injection in Subjects With Stage 5 CKD and SHPT on Hemodialysis

Conditions
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Chronic Kidney Disease, Secondary Hyperparathyroidism, Chronic Renal Insufficiency, Chronic Renal Failure

Intervention / Treatment
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* Drug: CTAP201 Injection
* Drug: Doxercalciferol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index between 18 and 40 On maintenance hemodialysis three times per week Visit 1: Serum iPTH value greater than or equal to 200 pg/mL and lower than or equal to 1000 pg/mL Visit 1: Serum total calcium value greater than 8.4 mg/dL and lower than 10.0 mg/dL Visit 1: Serum phosphorus value greater than or equal to 2.5 mg/dL and lower than or equal to 5.5 mg/dL Serum 25-hydroxyvitamin D level greater than or equal to 15 ng/mL Visit 2: Serum iPTH value greater than 300 pg/mL Visit 2: Serum Ca x P product less than 56 [mg/dl]2 Willing and able to discontinue vitamin D and/or bone metabolism therapy for at least 2 weeks prior to administration of Study Drug, and length of study Exclusion Criteria: Taking cytochrome P450 3A inhibitors and/or inducers Abnormal liver functions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CTAP201 Injection at dose a<br>CTAP201 at dose a | Drug: CTAP201 Injection<br>* Comparison of different dose strengths of CTAP201 after single dose.<br>|
| Experimental: CTAP201 Injection<br>CTAP201 at dose b or dose c | Drug: CTAP201 Injection<br>* Comparison of different dose strengths of CTAP201 after single dose.<br>|
| Active Comparator: Doxercalciferol at dose a<br>Active at dose a | Drug: Doxercalciferol<br>* Comparison of different dose strengths of doxercalciferol after single dose.<br>* Other names: Hectorol;|
| Active Comparator: Doxercalciferol<br>Active at dose b or dose c | Drug: Doxercalciferol<br>* Comparison of different dose strengths of doxercalciferol after single dose.<br>* Other names: Hectorol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood levels of CTAP201 and doxercalciferol |  | Day 1 and Day 15 of each dose level | 
| Safety of a single dose of CTAP201 Injection |  | Throughout the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, Parathyroid Diseases, Renal Insufficiency, Kidney Failure, Chronic, Hyperparathyroidism, Secondary, Hyperparathyroidism, Renal Insufficiency, Chronic, Kidney Diseases, Kidney Failure