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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00792857

Enrollment

Registered

2008-11-18

Start date

2008-11-30

Completion date

2009-10-31

Last updated

2014-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Parathyroid Diseases, Renal Insufficiency, Kidney Failure, Chronic, Hyperparathyroidism, Secondary, Vitamin D, Hyperparathyroidism, Renal Insufficiency, Chronic, Kidney Diseases, Kidney Failure

Brief summary

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.

Interventions

DRUGCTAP201 Injection

Comparison of different dose strengths of CTAP201 after single dose.

DRUGDoxercalciferol

Comparison of different dose strengths of doxercalciferol after single dose.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026