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

NCT01289301 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2011-02-03

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

mTOR inhibitor (everolimus)

calcineurin-inhibitor based immunosuppression will be switched to immunosuppression based on m-TOR inhibitor (everolimus trough level 3-7ng/mL)

DRUG

cyclosporine or tacrolimus

calcineurin inhibitor (cyclosporine or tacrolimus) will be continued (trough level 60-90ng/mL resp 3-7ng/mL)

Sponsors & Collaborators

  • Hannover Medical School

    lead OTHER

Principal Investigators

  • Anke Schwarz, Prof. Dr. · Hannover Medical School, Nephrology

  • Hermann Haller, Prof. Dr. · Hannover Medical School, Nephrology

  • Silvia Linnenweber, Dr. · Hannover Medical School, Nephrology

  • Armin Koch, Prof. Dr. · Hannover Medical School, Biometry

  • Albert Heim, PD Dr. · Hannover Medical School, Virology

  • Verena Broecker, Dr. · Hannover Medical School, Pathology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2017-10-31
Completion
2018-10-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01289301 on ClinicalTrials.gov