Study of FK778 in Renal Transplant Recipients With Untreated BK Nephropathy - Full Text View

Sponsors and Collaborators:	Astellas Pharma Inc Astellas Pharma US, Inc.
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00104338

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 II

MedlinePlus related topics: Kidney Transplantation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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

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 22 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Astellas Pharma US, Inc.

More Information

Study ID Numbers:	04-0-196
Study First Received:	February 24, 2005
Last Updated:	July 12, 2006
ClinicalTrials.gov Identifier:	NCT00104338
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

Study placed in the following topic categories:

Urologic Diseases
Kidney Diseases

ClinicalTrials.gov processed this record on January 16, 2009