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Mechanisms and Treatment of Chronic Allograft Injury (CAI) Due to Calcineurin Inhibitor (CNI) Toxicity

NCT01473732 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2018-10-16

Study results available
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Summary

The purpose of this study is to find out how well the current drug regimen (including low Prograf dose and Myfortic, which is usually recommended to prevent any further deterioration in the kidney function) works and how safe it is when compared to a combination of Zortress and Myfortic in patients with chronic kidney injury associated with Prograf or Neoral use.

Conditions

  • Chronic Allograft Injury
  • Calcineurin Inhibitor Toxicity

Interventions

DRUG

Everolimus

Starting dose 1.5 mg bid, target trough level 6-10 ng/ml.

DRUG

Tacrolimus

Target trough level of Tacrolimus 3-5 ng/ml.

DRUG

Mycophenolic acid

Myfortic Min. dose 360 mg bid and Max dose 720 mg bid. Used in both arms. Used for one year.

Sponsors & Collaborators

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Enver Akalin, MD · Montefiore Medical Center/AECOM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01473732 on ClinicalTrials.gov