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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01636466
Other study ID # IRB00059278
Secondary ID CRAD001AUS191T
Status Terminated
Phase Phase 3
First received July 5, 2012
Last updated January 9, 2018
Start date June 2013
Est. completion date May 2014

Study information

Verified date January 2018
Source Emory University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to test the safety and effectiveness of everolimus (Zortress®) in preventing antibody formation in patients with chronic failing kidney transplants. Everolimus (Zortress®) is approved by the U.S. Food and Drug Administration for the prevention of rejection in kidney transplant.

The primary objective for the study is to determine whether conversion of patients with chronic renal graft failure approaching dialysis to an everolimus-based regimen will prevent allosensitization. The secondary objective will be to determine whether conversion of patients with chronic renal graft failure to everolimus (elimination of calcineurin inhibitor) will delay the onset of dialysis.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- recipient of deceased or living donor kidney transplant

- Age 18-75 years (inclusive)

- Male or female

- renal allograft dysfunction/deterioration evidenced by glomerular filtration rate (GFR) less than or equal to 35

- Grade 2 or 3 Interstitial fibrosis/tubular atrophy (IF/TA) on renal allograft biopsy within 5 years of enrollment

- Willing and able to provide informed consent for study participation

Exclusion Criteria:

- Prior solid organ transplant (other than kidney)

- History of donor-specific antibody

- History of biopsy-proven acute rejection within 1 year prior to enrollment

- Proteinuria greater than or equal to 1.5 gm on spot urine protein/creatinine ratio

- Evidence of Hepatitis C virus infection (antibody positive or polymerase chain reaction(PCR) positive)

- Epstein Barr Virus (EBV) or cytomegalovirus (CMV) viremia at the time of enrollment

- Subjects receiving belatacept (Nulojix)

- Pregnant or nursing (lactating) women

- Women of child-bearing potential (WOCBP) who are unwilling or unable to use two birth-control methods throughout participation in the study

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Everolimus
Everolimus will initially be dosed at 0.75 mg tablet taken orally twice a day. The dose will be adjusted to maintain serum trough concentrations of 5-8 ng/ml.

Locations

Country Name City State
United States Emory University Atlanta Georgia

Sponsors (2)

Lead Sponsor Collaborator
Ashtar Chami Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Fluorescence Index (MFI) of Donor Specific Alloantibodies (DSA) Development of new donor-specific alloantibody as determined by solid phase bead array (Luminex) technology defining MFIs for fine specificity at Class I and Class II antigens (human leukocyte antigens (HLA) - A, B, C, DR, DP, and DQ) with an MFI >5000 defined as positive 36 months
Secondary Incidence of Return to Dialysis Dependence 36 months
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