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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

SIMPLE Trial 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%).Check my eligibility
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.See study design
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.

SIMPLE Trial 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.

SIMPLE Trial 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

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

SIMPLE 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
906 Previous Clinical Trials
1,596,208 Total Patients Enrolled
Veloxis PharmaceuticalsIndustry Sponsor
41 Previous Clinical Trials
3,066 Total Patients Enrolled
Santhi Voora, MDPrincipal Investigator - University of Southern California
University of Southern California

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any prerequisites to joining this medical trial?

"This trial seeks 80 renal transplant patients in the age range of 18 to 85. Specifically, those with a cold ischemia time (CIT) less than 24 hours for 3-6 HLA mismatches between donor and recipient as well as CIT exceeding 24 hours when there are fewer than three mismatches must meet their selection criteria."

Answered by AI

Are there presently any opportunities to join this experiment?

"Affirmative. According to the clinicaltrials.gov page, this study is still in search of patients. It was first posted on November 23rd 2021 and recently updated on June 6th 2022. The research team intends to enroll 80 participants at one medical centre for the duration of the trial."

Answered by AI

What is the total prospective participant count of this research?

"Affirmative. The information shared on clinicaltrials.gov implies that this medical trial is still open for recruitment, having been first posted on November 23rd 2021 and last updated June 6th 2022. 80 participants are required across one site in order to further the study's research goals."

Answered by AI

Does the protocol for this trial limit participation to those under 35 years of age?

"This medical trial has established that applicants must fall within the age range of 18 to 85. For minors, there are 177 trials available and 615 for those over 65 years old."

Answered by AI

What have past investigations revealed about the efficacy of Once-daily Regimen?

"Currently, 639 Once-daily Regimen clinical trials are in progress. Of these, 147 have reached Phase 3 of the study. While Philadelphia has a high concentration of trials for this treatment option, there are 18,727 locations participating globally."

Answered by AI

What illnesses can be treated with a single-dose regimen?

"Patients suffering from scalp structure issues, thyroiditis, atopic dermatitis can seek relief through a Once-daily Regimen."

Answered by AI

Has the FDA green-lighted Once-daily Regimen for consumer use?

"The once-daily regimen has been approved and is thus rated at 3 on our safety scale. This reflects the fact that this medication is currently in a Phase 4 clinical trial."

Answered by AI
Recent research and studies
~19 spots leftby Feb 2025