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Immunosuppressant

Simplified Immunosuppression for Kidney Transplant (SIMPLE Trial)

Phase 4
Recruiting
Led By Santhi Voora, MD
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
De- Novo Kidney transplant patients between 18 and 85 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 12 months
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial is comparing two different immunosuppressive drug combinations to see which one results in better outcomes for kidney transplant patients.

Who is the study for?
This trial is for adults aged 18-85 who have recently received a kidney transplant. They should have a cold ischemia time of less than 24 hours if there's a significant mismatch in donor and recipient tissue types, or more than 24 hours for fewer mismatches. Their pre-transplant antibody levels must be low (≤20%).
What is being tested?
The study tests whether taking EnvarsusXR (a once-daily tacrolimus) with Azathioprine works as well as the standard treatment of twice-daily Tacrolimus with Mycophenolate mofetil/acid to prevent organ rejection without affecting patient survival.
What are the potential side effects?
Possible side effects include increased risk of infections, high blood pressure, tremors, possible kidney damage, diabetes after transplantation, gastrointestinal issues like diarrhea and nausea, and potential bone marrow suppression leading to anemia or low white cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 85 years old and have received a new kidney transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To compare the composite incidence of biopsy proven acute rejection, graft survival and patient survival
Secondary study objectives
Adverse Events
BK Viremia
Cancer
+12 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Twice-daily RegimenActive Control4 Interventions
Twice-daily regimen of immediate release tacrolimus, mycophenolate mofetil (MMF)/mycophenolic acid (MPA) plus daily methylprednisolone or prednisone.
Group II: Once-daily RegimenActive Control4 Interventions
Once-daily regimen of Envarsus, azathioprine plus methylprednisolone or prednisone.

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
944 Previous Clinical Trials
1,604,565 Total Patients Enrolled
Veloxis PharmaceuticalsIndustry Sponsor
41 Previous Clinical Trials
2,990 Total Patients Enrolled
Santhi Voora, MDPrincipal Investigator - University of Southern California
University of Southern California
~4 spots leftby Feb 2025
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