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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
History of Changes
  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:

U.S. FDA Resources

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

  Show 21 Study Locations
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 May 23, 2013