ISRCTN40228609CompletedNot Applicable
BK Viremia: Kinase Inhibition to Decrease Nephropathy Intervention - a phase III multicentre randomised parallel group trial
niversity of Calgary (Canada)0 sites300 target enrollmentStarted: February 2, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 300
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Current inclusion criteria as of 01/02/2013:
- •1. All adults (aged greater than or equal to 18 years, either sex) de novo renal transplant patients with grafts from both living donors and deceased donors and up to two renal transplants prior to the current transplant
- •2. Presence of BK viremia based on a positive BK virus deoxyribonucleis acid polymerase chain reaction (DNA PCR) in plasma, of any degree
- •3. Greater than 1 month post-kidney transplant
- •4. Provision of informed consent (self or legal representative)
- •Previous inclusion criteria:
- •1. All adults (aged greater than or equal to 18 years, either sex) de novo renal transplant patients with grafts from both living donors and deceased donors and up to two renal transplants prior to the current transplant
- •2. Presence of BK viremia based on a positive BK virus deoxyribonucleis acid polymerase chain reaction (DNA PCR) in plasma, of any degree
- •3. Greater than 2 months post-kidney transplant
- •4. Provision of informed consent (self or legal representative)
Exclusion Criteria
- •Current exclusion criteria as of 05/02/2013:
- •1. Fourth or subsequent renal transplant
- •2. Multiorgan transplant
- •3. Cold ischemia time for current transplant exceeding 36 hours
- •4. Pregnancy, breastfeeding , or women of child bearing potential not willing to use a reliable method of contraception
- •5. Current involvement in another interventional trial (observational follow-up is permitted)
- •6. Known allergy to sirolimus or leflunomide
- •7. Pre-existing liver disease including Hepatitis B or C
- •8. Poor renal function due to causes other than BK virus, as determined by the site Qualified Investigator
- •Previous exclusion criteria:
- •1. Fourth or subsequent renal transplant
- •2. Multiorgan transplant
- •3. Cold ischemia time for current transplant exceeding 36 hours
- •4. Patients with BK viremia less than 2 months after transplant
- •5. Pregnancy or breastfeeding
- •6. Involvement in another drug trial
- •7. Known allergy to sirolimus or leflunomide
- •8. Pre-existing liver disease including hepatitis B or C
- •Added 17/08/2010:
- •9. Persistent estimated glomerular filtration rate (eGFR) less than 30 ml/min/1.73 m^2 for a period of at least 2 weeks in duration
Investigators
Similar Trials
Not yet recruiting
Phase 2
Reduction of BK viremia in kidney transplant patients using the Seraph 100 Microbind® Affinity (Seraph 100) Blood FilterDRKS00024859ExThera Medical Corporation40
Withdrawn
Not Applicable
Reduction of BK Viremia in Kidney Transplant PatientsKidney DiseasesKidney Transplant InfectionKidney Transplant ComplicationsNCT04984902ExThera Medical Europe BV40
Completed
Phase 4
Intravenous Immunoglobulins for Prevention of BKV Infection in Kidney Transplant Recipients According to BKV Genotype-specific Neutralizing Antibody Titers at the Day of Transplantation.Kidney TransplantationNCT04222023University Hospital, Strasbourg, France359
Unknown
Not Applicable
Role of Anti-BK Virus Neutralizing Antibodies (BKV) as a Prognostic Marker for the Development of Nephropathy BKGraft DysfunctionNCT02826811University Hospital, Strasbourg, France170
Active, not recruiting
Phase 1
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 - POLYOMA STUDYPolyoma BK-virus nephropathy is a viral complication after renal transplantation attacking up to 10% of renal transplants and causing transplant failure in 45% of cases. No virustatic treatment exists. Modifying the infection is usually tried by lowering immunosuppression, which may lead to transplant failure by rejection as well. A randomized switch of immunosuppression to everolimus vs general lowering of immunosuppression has to be tested (prospect. random. parallel group comparison).EUCTR2008-005925-12-DEMedizinische Hochschule Hannover120