Clinical trial

SIMPLE Study: A Prospective and Randomized Trial of a Simplified Immunosuppressive Protocol Utilizing Low Dose EnvarsusXR

Name

HS-18-00513

Description

The purpose of this study is to determine if the combination of once-daily tacrolimus extended-release (EnvarsusXR) and Azathioprine is non inferior with respect to the composite outcome of acute rejection, graft and patient survival as compared to a combination of twice-daily immediate release tacrolimus and mycophenolate mofetil/mycophenolic acid.

Trial arms

Trial start

2021-11-23

Estimated PCD

2025-02-01

Trial end

2025-02-01

Status

Recruiting

Phase

Early phase I

Treatment

Twice-daily Tacrolimus

Within 48 hours of transplantation, immediate release tacrolimus (IRT) (0.1 mg/kg /day) will be administered twice a day.

Arms:

Twice-daily Regimen

Once-daily envarsus XR

Within 48 hours of transplantation, Envarsus XR (0.13mg/kg/day) will be administered once a day.

Arms:

Once-daily Regimen

Induction Immunosuppression with Basiliximab or Rabbit Anti Thymoglobulin (rATG)

Induction immunosuppression with Basiliximab or Rabbit Anti Thymoglobulin (rATG) per protocol. The dose of Basiliximab will be a standard of two 20 mg doses and total rATG will not exceed 6 mg/kg.

Arms:

Once-daily Regimen, Twice-daily Regimen

Methylprednisolone, prednisone

Methylprednisolone intraoperatively (500mg) and immediately post transplantation (200mg on post operative day (POD) #1, 150mg on POD#2, 100mg on POD#3) then oral prednisone (50mg on POD #4, 20mg on POD #5). Oral prednisone will be tapered down to a minimal dose of 5mg within 6 weeks post transplantation.

Arms:

Once-daily Regimen, Twice-daily Regimen

Other names:

Steroids

Mycophenolate mofetil (MMF) or Mycophenolic acid (MPA)

Mycophenolate mofetil (MMF) (up to 1000mg) or Mycophenolic acid (MPA) (up to 720mg) will be administered twice a day.

Arms:

Twice-daily Regimen

Other names:

Twice a day anti-metabolite

Azathioprine

Azathioprine (1-3 mg/kg) will be administered once a day.

Arms:

Once-daily Regimen

Other names:

Once a day anti-metabolite

Size

Primary endpoint

To compare the composite incidence of biopsy proven acute rejection, graft survival and patient survival

3 months

To compare the composite incidence of biopsy proven acute rejection, graft survival and patient survival

6 months

To compare the composite incidence of biopsy proven acute rejection, graft survival and patient survival

12 months

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is an open-label, randomized, prospective clinical trial. Patients will be screened prior to surgery and randomized 1:1 to each arm.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}

Updated at

2023-12-05

1 organization

6 products

2 indications

Product

Basiliximab

Organization

University of Southern California

Indication

Kidney Transplant

Indication