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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
  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
Intervention Model: Parallel Assignment
Masking: None (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00104338


  Show 21 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma US, Inc.
  More Information

ClinicalTrials.gov Identifier: NCT00104338     History of Changes
Other Study ID Numbers: 04-0-196
First Submitted: February 24, 2005
First Posted: February 25, 2005
Last Update Posted: June 7, 2012
Last Verified: June 2012

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