Using mTOR Inhibitors in the Prevention of BK Nephropathy

NCT01649609 | Completed Results DMC

• 2 other identifiers: AAAI9004WS2036051
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

BK Viremia; BK Nephropathy

Keywords

BK Viremia; BK Nephropathy; mTOR inhibitor; renal transplant

Outcome Measures

Primary Outcomes (1)

• Number of Participants With BK Viral Load <600 Copies/mL

  A Viral load of \<600 copies/mL for at least 3 months indicates sustained clearance of BK viremia, confirmed by blood test

  Up to 12 months from enrollment

Secondary Outcomes (1)

• Number of Participants With Incidence of BK Nephropathy

  Up to 24 months from randomization

Study Arms (2)

Reduction of standard immunosuppression

ACTIVE COMPARATOR

Low dose Tacrolimus with low dose Mycophenolate acid

Drug: Tacrolimus; Drug: Mycophenolate acid

mTOR Arm

ACTIVE COMPARATOR

Low dose Sirolimus with low dose Mycophenolate acid (mTOR Substitution)

Drug: Mycophenolate acid; Drug: Sirolimus

Interventions

Tacrolimus DRUG

Reduction of standard immunosuppression - The standard of care immunosuppression treatment commonly used for renal transplant patients

Also known as: Prograf

Reduction of standard immunosuppression

Mycophenolate acid DRUG

Myfortic or CellCept - The standard of care immunosuppression treatment most commonly used for renal transplant patients

Also known as: mycophenolate antimetabolite

Reduction of standard immunosuppression; mTOR Arm

Sirolimus DRUG

mTOR Substitution - Replacing tacrolimus (a calcineurin inhibitor) with sirolimus (an mTOR inhibitor) along with reduction of mycophenolic acid

Also known as: Rapamune

mTOR Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Renal transplant recipients age 18 years or over

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead
• Pfizer: collaborator
• Cornell University: collaborator

Study Sites (2)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Weill Cornell Medical Center

New York, New York, 10065, United States

Location

MeSH Terms

Interventions

Tacrolimus; Mycophenolic Acid; Sirolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids

Results Point of Contact

• Title: Sumit Mohan, MD
• Organization: Columbia University Medical Center

sm2206@cumc.columbia.edu

2123053273

Study Officials

• Sumit Mohan, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Medicine

Study Record Dates

• First Submitted: July 23, 2012
• First Posted: July 25, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 28, 2018
• Results First Posted: February 28, 2018

Record last verified: 2018-01

Locations

US (2)