Trials / Unknown
UnknownNCT01289301
Studying the Effect of Changing Immunosuppression in Case of Polyoma BK Virus Infection of the Renal Transplant
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
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 124 (estimated)
- Sponsor
- Hannover Medical School · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2011-10-01
- Primary completion
- 2017-10-01
- Completion
- 2018-10-01
- First posted
- 2011-02-03
- Last updated
- 2011-02-03
Locations
4 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT01289301. Inclusion in this directory is not an endorsement.