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

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Chronic Renal Failure Chronic Renal Insufficiency 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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pivotal Reseach Centers, Peoria, Arizona, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

CTAP201 Injection

Drug

Comparison of different dose strengths of CTAP201 after single dose.

Doxercalciferol

Drug

Comparison of different dose strengths of doxercalciferol after single dose.

Other names: Hectorol

Primary outcomes

Blood levels of CTAP201 and doxercalciferol

Time frame: Day 1 and Day 15 of each dose level
Safety of a single dose of CTAP201 Injection

Time frame: Throughout the study

Sponsors and collaborators

Lead sponsor

OPKO IP Holdings II, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Nov 18, 2008
Registry last updated: Sep 29, 2014

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.

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

Completed