NCT00792857

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

September 29, 2014

Status Verified

November 1, 2009

Enrollment Period

10 months

First QC Date

November 14, 2008

Last Update Submit

September 26, 2014

Conditions

Chronic Kidney DiseaseSecondary HyperparathyroidismChronic Renal InsufficiencyChronic Renal Failure

Keywords

Parathyroid DiseasesRenal InsufficiencyKidney Failure, ChronicHyperparathyroidism, SecondaryVitamin DHyperparathyroidismRenal Insufficiency, ChronicKidney DiseasesKidney Failure

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (4)

CTAP201 Injection at dose a

EXPERIMENTAL

CTAP201 at dose a

Drug: CTAP201 Injection

CTAP201 Injection

EXPERIMENTAL

CTAP201 at dose b or dose c

Drug: CTAP201 Injection

Doxercalciferol at dose a

ACTIVE COMPARATOR

Active at dose a

Drug: Doxercalciferol

Doxercalciferol

ACTIVE COMPARATOR

Active at dose b or dose c

Drug: Doxercalciferol

Interventions

CTAP201 InjectionDRUG

Comparison of different dose strengths of CTAP201 after single dose.

CTAP201 InjectionCTAP201 Injection at dose a
DoxercalciferolDRUG

Comparison of different dose strengths of doxercalciferol after single dose.

Also known as: Hectorol
DoxercalciferolDoxercalciferol at dose a

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Taking cytochrome P450 3A inhibitors and/or inducers
  • Abnormal liver functions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Pivotal Reseach Centers

Peoria, Arizona, 85381, United States

Location

Western New England Renal and Transplant Associates

Springfield, Massachusetts, 01107, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45206, United States

Location

Northeast Clinical Research

Allentown, Pennsylvania, 18103-6379, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Southwest Houston Research Ltd.

Houston, Texas, 77099, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicHyperparathyroidism, SecondaryKidney Failure, ChronicParathyroid DiseasesRenal InsufficiencyHyperparathyroidismKidney Diseases

Interventions

1 alpha-hydroxyergocalciferol

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsEndocrine System Diseases

Study Officials

  • Joel Melnick, MD

    OPKO Renal

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2008

First Posted

November 18, 2008

Study Start

November 1, 2008

Primary Completion

September 1, 2009

Study Completion

October 1, 2009

Last Updated

September 29, 2014

Record last verified: 2009-11

Locations

US(6)