Status:
COMPLETED
Extended Release Tacrolimus vs. Twice-Daily Tacrolimus
Lead Sponsor:
Lorenzo Gallon
Conditions:
End Stage Renal Disease
Rejection of Renal Transplant
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The overall aim of the study is to prospectively investigate the impact of two maintenance calcineurin inhibitor immunosuppressive regimens: once-daily extended release tacrolimus and twice-daily tacr...
Detailed Description
Kidney transplantation is the treatment of choice for most patients with end-stage renal disease. Lifelong immunosuppressive therapies are required to prevent organ rejection. However, long term expos...
Eligibility Criteria
Inclusion
- 1\. Patients who are males or females aged 18-65 years. 2. Use of the following induction medications: basiliximab and rituximab. 2. Donors aged 18-65 years. 3. No prior organ transplant 4. Patients who are single-organ recipients (kidney only). 5. Women who are of childbearing potential must have a negative serum pregnancy test before transplantation and agree to use a medically acceptable method of contraception throughout the treatment period.
- 6\. Subject (recipient) is able to understand the consent form and give written informed consent
Exclusion
- Delayed graft function (please see above).
- Known sensitivity or contraindication to alemtuzumab, Envarsus® XR, tacrolimus or MMF.
- Use of the following induction medications: basiliximab and rituximab
- Patient with significant or active infection.
- Patients with a positive flow cytometric crossmatch using donor lymphocytes and recipient serum.
- Patients with PRA \> 40%
- Patients with current or historic donor specific antibodies
- Body Mass Index (BMI) of \< 18 or \> 35
- Patients who are pregnant or nursing mothers.
- Patients whose life expectancy is severely limited by diseases other than renal disease.
- Ongoing active substance abuse, drug or alcohol.
- Major ongoing psychiatric illness or recent history of noncompliance.
- Significant cardiovascular disease (e.g.):
- Significant non-correctable coronary artery disease;
- Ejection fraction below 30%;
- History of recent myocardial infarction.
- Malignancy within 3 years, excluding non-melanoma skin cancers.
- Serologic evidence of infection with HIV or HBVs-Ag positive.
- Patients with a screening/baseline total white blood cell count \< 4,000/mm3; platelet count \< 100,000/mm3; triglyceride \> 400 mg/dl; total cholesterol \> 300 mg/dl.
- Investigational drug within 30 days prior to transplant surgery.
- Anti-T cell therapy within 30 days prior to transplant surgery.
- Diagnosis of atypical-Hemolytic Uremic Syndrome (aHUS).
- Subjects transplanted with a Hepatitis C NAT-positive kidney.
Key Trial Info
Start Date :
September 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2021
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT03289650
Start Date
September 5 2017
End Date
February 23 2021
Last Update
April 10 2023
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611