Study of FK778 in Renal Transplant Recipients With Untreated BK Nephropathy

This study has been terminated.
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00104338
First received: February 24, 2005
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

The purpose of this study is to assess the safety and effectiveness of a new oral immunosuppressant agent compared to standard care in renal transplant patients diagnosed with BK nephropathy.


Condition Intervention Phase
BK Polyomavirus
Kidney Diseases
Drug: FK778
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Proof of Concept, Randomized, Open-label, Two-arm, Parallel Group, Multi-center Study to Assess the Efficacy and Safety of FK778 Compared With Standard Care in Renal Transplant Recipients With Untreated BK Nephropathy

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Change from baseline in urine BK viral load

Secondary Outcome Measures:
  • Change from baseline in plasma BK viral load
  • Change from baseline in renal function as measured by serum creatinine (SCr) and creatinine clearance (CrCl) at month 6 or at the end of therapy, whichever is earlier
  • Change from baseline in renal histology measured by Drachenberg criteria at month 6 or at the end of therapy, whichever is earlier

Estimated Enrollment: 45
Study Start Date: January 2005
Study Completion Date: August 2006
Detailed Description:

The purpose of this study is to assess the efficacy and safety of FK778 compared with standard care in renal transplant recipients with newly diagnosed and untreated BK nephropathy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Renal transplant recipient with newly diagnosed BK nephropathy.

Exclusion Criteria:

  • Previous treatment for BK nephropathy
  • Organ transplant other than kidney
  • Uncontrolled concomitant infection other than BK nephropathy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00104338

  Hide Study Locations
Locations
United States, California
Los Angeles, California, United States, 90057
Los Angeles, California, United States, 90095
San Diego, California, United States, 92123
San Francisco, California, United States, 94115
San Francisco, California, United States, 94143
United States, Colorado
Denver, Colorado, United States, 80262
United States, District of Columbia
Washington, District of Columbia, United States, 20010
United States, Florida
Gainesville, Florida, United States, 32610
Jacksonville, Florida, United States, 32216
United States, Georgia
Atlanta, Georgia, United States, 30322
United States, Illinois
Chicago, Illinois, United States, 60637
Chicago, Illinois, United States, 60612
United States, Kansas
Wichita, Kansas, United States, 67214
United States, Maryland
Baltimore, Maryland, United States, 21287
United States, New Jersey
New Brunswick, New Jersey, United States, 08901
United States, North Carolina
Durham, North Carolina, United States, 22710
United States, Ohio
Cincinnati, Ohio, United States, 45267
United States, Pennsylvania
Harrisburg, Pennsylvania, United States, 17104
United States, Tennessee
Memphis, Tennessee, United States, 38014
United States, Utah
Salt Lake City, Utah, United States, 84132
United States, Virginia
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma US, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00104338     History of Changes
Other Study ID Numbers: 04-0-196
Study First Received: February 24, 2005
Last Updated: June 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Investigational Therapies
Treatment Effectiveness
Treatment Efficacy
Immunosuppressant
BK Nephropathy
Polyomavirus, BK
Human Polyomavirus BK
Polyomavirus hominis 1

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014