Studying the Effect of Changing Immunosuppression in Case of Polyoma BK Virus Infection of the Renal Transplant

Virus Diseases Clinical Trial

— BKVIRUS  

Official title:

Polyomavirus BK Nephropathy After Renal Transplantation: Randomized Clinical Trial to Demonstrate That Switching to mTOR Inhibitor is More Effective Than a Reduction of Immunosuppressive Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01289301
• Other study ID #: Polyoma IFB 29
• Status: Not yet recruiting
• Phase: Phase 4
• First received: February 2, 2011
• Last updated: February 2, 2011
• Start date: October 2011
• Est. completion date: October 2018

Study information

• Verified date: October 2010
• Source: Hannover Medical School
• Contact: Anke Schwarz, Prof. Dr.
• Phone: +49 511 532 2329
• Email: schwarz.anke[@]mh-hannover.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

Polyomavirus BK nephropathy is a serious complication after renal transplantation leading to graft loss in 40% of cases. Since no virustatic drug exists, the investigators want to study the best way to manage viral invasion by changing the immunosuppressive treatment comparing two treatment schemes. The investigators hypothesis is that switching to an mTOR-based scheme is superior to a general decrease of a calcineurin inhibitor (CNI)-based scheme. The study will be performed as a prospective, randomized, parallel group comparison.

Description:

The study group (n=62) will be switched from CNI to everolimus while the control group (n=62) will get a general reduction of the CNI-based immunosuppression. Follow-up and duration of intervention per patient will be 24 months, duration of the trial 72 months including 4 years of recruitment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 124
• Est. completion date: October 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• preceding renal transplantation

• functioning graft with a permanent creatinine clearance of more than 25mL/min

• biopsy-confirmed polyoma BK virus nephropathy

• age over 18 years old

Exclusion Criteria:

• allergy or non-tolerance of the study medication everolimus

• pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Disorder Related to Renal Transplantation
• Immunosuppression Related Infectious Disease
• Infection
• Virus Diseases

Intervention

Drug:
• mTOR inhibitor (everolimus)
calcineurin-inhibitor based immunosuppression will be switched to immunosuppression based on m-TOR inhibitor (everolimus trough level 3-7ng/mL)
• cyclosporine or tacrolimus
calcineurin inhibitor (cyclosporine or tacrolimus) will be continued (trough level 60-90ng/mL resp 3-7ng/mL)

Locations

Country	Name	City	State
Germany	University of Erlangen/ Nürnberg, Transplant Outpatient Clinic	Erlangen	Bayern
Germany	University of Essen, Transplant Outpatient Clinic	Essen	Ruhrgebiet
Germany	University Hospital Freiburg, Transplant Outpatient Clinic	Freiburg	Baden-Württemberg
Germany	Hannover Medical School, Transplant Outpatient Clinic	Hannover	Niedersachsen

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death or graft loss	after experimental intervention (switch to mTOR inhibitor in group 1) and control intervention (general reduction of immunosuppression) observation of graft function	2 years of observation	No
Secondary	decrease of polyomavirus serum PCR	regular measurement of polyomavirus serum PCR (every 4 weeks to 3 months)	2 years	No
Secondary	decrease of creatinine	regular measurment of graft function (every 4 weeks to 3 months)	2 years observation	No
Secondary	progression of chronic changes in renal histology	renal rebiopsy and comparison of chronic changes in renal biopsy with the diagnostic renal biopsy	renal biopsy 3 months after intervention	No
Secondary	number of rejections following intervention	biopsy-verified rejections (graft biopsies on indication) may be a consequence of changement of immunosuppression and a side effect of it, rejections will be counted	2 years after intervention	No
Secondary	increase of BKV-specific T-cells	increase of BKV-specific T-cells are a sign of overcoming viral infection and will be counted regularly (every 3 to 6 months)	2 years observation	No