NCT01620268

An Open-Label, Study to Treat Patients With Renal Allograft and Polyoma BK Viruria

An Open-Label, Phase 2 Study to Treat Patients With Renal Allograft and Polyoma BK Viruria to Prevent Polyoma BK Viremia, Polyoma BK Nephropathy and Renal Allograft Rejection

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Changzheng-Cinkate · Industry
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the clinical efficacy and safety of a combination of leflunomide and orotic acid in kidney transplant patients with high levels of Polyoma BK viruria for the purpose of preventing Polyoma BK viremia and Nephropathy that could lead to kidney transplant loss from viral damage, acute rejection or both.

Detailed description

This is a multicenter, randomized trial that will evaluate the effect of a combination of leflunomide and orotic acid for the treatment of Polyoma BK viruria. In this multicenter trial, renal allograft patients with the diagnosis of Polyoma BK viruria as determined by a viral level in the urine of 25 million or more copies/mL, and no detectable viremia, will complete a screening visit (V1) to determine eligibility for the study based on inclusion/exclusion criteria. Patients that meet the entrance criteria for this study will be randomly assigned to one of two treatment groups at Visit (2) and enter a 4 month dosing period.

Conditions

• Viruria
• Viremia

Interventions

Type	Name	Description
DRUG	Leflunomide and orotic acid	Daily dose of leflunomide adjusted to target steady state blood levels of 50 ug/mL to 100 ug/mL of the active metabolite plus 600 mg orotic acid

Timeline

• Start date: 2012-07-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2012-06-15
• Last updated: 2018-12-05

Locations

9 sites across 1 country: United States