Peoria, Arizona 85381

  • Chronic Renal Failure

Purpose:

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.


Criteria:

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


Study is Available At:


Original ID:

CTAP201-CL-1007


NCT ID:

NCT00792857


Secondary ID:


Study Acronym:


Brief Title:

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


Official 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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Opko Health, Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: P


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

24


Enrollment Type:

Actual


Overall Contact Information

Official Name:Joel Melnick, MD
Study Director
OPKO Renal

Study Dates

Start Date:November 2008
Completion Date:October 2009
Completion Type:Actual
Primary Completion Date:September 2009
Primary Completion Type:Actual
Verification Date:November 2009
Last Changed Date:September 26, 2014
First Received Date:November 14, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Safety of a single dose of CTAP201 Injection
Time Frame:Throughout the study
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Blood levels of CTAP201 and doxercalciferol
Time Frame:Day 1 and Day 15 of each dose level
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:CTAP201 Injection
Description:Comparison of different dose strengths of CTAP201 after single dose.
Arm Name:CTAP201 Injection at dose a
Intervention Type:Drug
Name:Doxercalciferol
Description:Comparison of different dose strengths of doxercalciferol after single dose.
Arm Name:Doxercalciferol at dose a
Other Name:Hectorol

Study Arms

Study Arm Type:Active Comparator
Arm Name:Doxercalciferol
Description:Active at dose b or dose c
Study Arm Type:Active Comparator
Arm Name:Doxercalciferol at dose a
Description:Active at dose a
Study Arm Type:Experimental
Arm Name:CTAP201 Injection
Description:CTAP201 at dose b or dose c
Study Arm Type:Experimental
Arm Name:CTAP201 Injection at dose a
Description:CTAP201 at dose a

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:OPKO IP Holdings II, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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