Using a simplified immunosuppressive regimen for kidney transplant patients
SIMPLE Study: A Prospective and Randomized Trial of a Simplified Immunosuppressive Protocol Utilizing Low Dose EnvarsusXR
This study is testing if a simpler once-a-day medication plan for kidney transplant patients can work just as well as the traditional twice-a-day plan while making it easier for them to stick to their treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Southern California Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT04773392 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a once-daily regimen of tacrolimus extended-release (EnvarsusXR) combined with Azathioprine, compared to the traditional twice-daily immediate release tacrolimus and mycophenolate mofetil. The goal is to determine if the new regimen can maintain similar outcomes in terms of acute rejection, graft survival, and patient survival while potentially reducing side effects and improving medication adherence. By simplifying the medication schedule, the study seeks to enhance the quality of life for kidney transplant recipients and improve compliance with their treatment plans.
Who should consider this trial
Good fit: Ideal candidates are de novo kidney transplant patients aged 18 to 85 with specific criteria regarding cold ischemia time and calculated panel reactive antibody levels.
Not a fit: Patients who are repeat kidney transplant recipients or have a calculated panel reactive antibody greater than 20% may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved patient adherence and reduced side effects, ultimately enhancing graft survival and patient outcomes.
How similar studies have performed: Previous studies have suggested that once-daily tacrolimus formulations may achieve therapeutic goals at lower doses, indicating potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * De- Novo Kidney transplant patients between 18 and 85 years old * Cold ischemia time (CIT) \< 24 hours for 3-6 HLA mismatches between donor and recipient and CIT \>24 hours for HLA mismatch of less than 3 between donor and recipient * Most recent pre-transplant cPRA (calculated panel reactive antibody) ≤ 20% Exclusion Criteria: * Repeat kidney transplant recipients * cPRA \>20% * rATG (rabbit anti-thymocyte globulin) induction \>6mg/kg at time of induction * Crossmatches deemed positive by accepting physician * Presence of pre-formed anti-HLA (anti-Human Leukocyte Antigen) DSA (Donor-Specific Antibody) as defined by MFI (mean fluorescence intensity) approaching 3000 using flow cytometry/Luminex-based, specific anti-HLA antibody testing. * Receipt of desensitization protocols * History of skin cancer * Recipient of multi-organ or dual kidney transplants * For any condition, in which the investigator's opinion makes the subject unsuitable for study
Where this trial is running
Los Angeles, California
- University of Southern California — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Santhi Voora, MD — University of Southern California
- Study coordinator: Melissa Ramos, BSN
- Email: Melissa.Ramos@med.usc.edu
- Phone: 323-442-7983
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.