BK Viremia: Kinase Inhibition to Decrease Nephropathy Intervention Trial

Completed

• Conditions: BK nephropathy; Urological and Genital Diseases; Unspecified nephritic syndrome

• Registration Number: ISRCTN40228609
• Lead Sponsor: niversity of Calgary (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-02
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified