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

Tracking Information
First Received Date ^ICMJE	February 24, 2005
Last Updated Date	June 6, 2012
Start Date ^ICMJE	January 2005
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Change from baseline in urine BK viral load
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00104338 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 23, 2005)	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
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of FK778 in Renal Transplant Recipients With Untreated BK Nephropathy
Official Title ^ICMJE	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
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.
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 ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	BK Polyomavirus Kidney Diseases
Intervention ^ICMJE	Drug: FK778
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	45
Completion Date	August 2006
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00104338
Other Study ID Numbers ^ICMJE	04-0-196
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Astellas Pharma Inc
Collaborators ^ICMJE	Astellas Pharma US, Inc.
Investigators ^ICMJE	Not Provided
Information Provided By	Astellas Pharma Inc
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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