Using mTOR Inhibitors in the Prevention of BK Nephropathy

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

BK virus infections after kidney transplant are increasing and can result in damage to the transplanted kidney. Currently, the universally accepted treatment is to decrease the strength of the antirejection medications but it is unclear what medications should be lowered and to what extent. The investigators propose to perform a study with patients who have BK virus detected in their blood during routine screening that appears to be increasing. The investigators will use two different strategies that involve different combinations of standard anti-rejection medications at lower dosages. Patients will be assigned to one of the two groups in a random manner across the two hospitals participating in the study. Patients will be followed for at least a year to determine if one strategy was more effective than the other in preventing an increase in the number of viruses in the blood stream and whether either one was more effective in reducing the negative impact of the infection on the functioning of the transplanted kidney.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Collaborators: Cornell University; Pfizer
• Treatments: Antimetabolites; Everolimus; Mycophenolate mofetil; Mycophenolic Acid; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

• Renal transplant recipients age 18 years or over

Exclusion Criteria:

• Patients with multiorgan transplants

• Patients on immunosuppressive regimens that include steroids or Sirolimus at the time of detection of viremia

• ABO incompatible renal transplants

• Three or more previous renal transplants

• Patients with contraindications to tacrolimus, sirolimus, mycophenolate mofetil or mycophenolic acid.