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Study of FK778 in Renal Transplant Recipients With Untreated BK Nephropathy

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00104338
First Posted: February 25, 2005
Last Update Posted: June 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Astellas Pharma US, Inc.
Information provided by:
Astellas Pharma Inc
February 24, 2005
February 25, 2005
June 7, 2012
January 2005
Not Provided
Change from baseline in urine BK viral load
Same as current
Complete list of historical versions of study NCT00104338 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Study of FK778 in Renal Transplant Recipients With Untreated BK Nephropathy
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
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • BK Polyomavirus
  • Kidney Diseases
Drug: FK778
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
45
August 2006
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00104338
04-0-196
Not Provided
Not Provided
Not Provided
Not Provided
Astellas Pharma Inc
Astellas Pharma US, Inc.
Not Provided
Astellas Pharma Inc
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP