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Terminated Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT01620268

Public ClinicalTrials.gov record NCT01620268. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 9:05 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01620268
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 2
Lead sponsor
Changzheng-Cinkate
Industry
Enrollment
24 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
Up to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 2012 (Actual)
Primary completion
Jun 2018 (Actual)
Completion
Jun 2018 (Actual)
Last update posted
Dec 5, 2018

2012 – 2018

United States locations

U.S. sites
9
U.S. states
7
U.S. cities
7
Facility City State ZIP Site status
University of Alabama, Birmingham Birmingham Alabama 35294 —
Tampa General Hospital Tampa Florida 33606 —
Rush Univeristy Chicago Illinois 60612 —
University of Illinois, Chicago Chicago Illinois 60612 —
The University of Chicago Transplant Center Chicago Illinois 60637 —
IU Health Indianapolis Indiana 46202 —
University of Lousiville Louisville Kentucky 40202 —
Beth Israel Deaconess Hospital Boston Massachusetts 02215 —
Methodist University Hospital Memphis Tennessee 38104 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01620268, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 5, 2018 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01620268 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →