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Study of FK778 in Renal Transplant Recipients With Untreated BK Nephropathy

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ClinicalTrials.gov Identifier: NCT00104338
Recruitment Status : Terminated
First Posted : February 25, 2005
Last Update Posted : June 7, 2012
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by:
Astellas Pharma Inc

Brief Summary:
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 or disease Intervention/treatment Phase
BK Polyomavirus Kidney Diseases Drug: FK778 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 45 participants
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
Study Start Date : January 2005
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine





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

Secondary Outcome Measures :
  1. Change from baseline in plasma BK viral load
  2. 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
  3. Change from baseline in renal histology measured by Drachenberg criteria at month 6 or at the end of therapy, whichever is earlier


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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.

ClinicalTrials.gov Identifier: NCT00104338     History of Changes
Other Study ID Numbers: 04-0-196
First Posted: February 25, 2005    Key Record Dates
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