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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01289301
Other study ID # Polyoma IFB 29
Secondary ID
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


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
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