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Calcineurin Inhibitor

Extended vs Immediate Release Tacrolimus for Kidney Transplant Rejection

Phase 4

Waitlist Available

Research Sponsored by Cedars-Sinai Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to understand and provide informed consent

Patients must have undergone desensitization with IVIG and rituximab with or without plasma exchange prior to transplant or be administered IVIG and rituximab peri-operatively (within seven days of transplant) post-transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial will compare outcomes of kidney transplant patients taking Envarsus XR versus tacrolimus. Outcomes include rejection rates, HLA antibodies, kidney function, and cell-free DNA levels.

Who is the study for?

This trial is for adults over 18 who've had a kidney transplant and were treated with IVIG and rituximab to reduce immune sensitivity. They must have an acceptable crossmatch from a non-identical donor. It's not for those allergic to the drugs being tested, with recent severe infections, conditions affecting drug absorption, or women at risk of pregnancy without contraception.Check my eligibility

What is being tested?

The study compares two forms of tacrolimus: extended-release (Envarsus XR) versus immediate-release in highly-sensitized kidney transplant recipients. It looks at rejection rates, antibody presence, kidney function via filtration rate, and levels of donor-derived DNA after 12 months.See study design

What are the potential side effects?

While specific side effects are not listed here, both forms of tacrolimus can generally cause immune system suppression leading to increased infection risk, potential damage to the kidneys or nervous system, high blood pressure, diabetes mellitus after transplantation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I understand the study and can give my consent.

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I have received or will receive IVIG and rituximab treatment around my transplant time.

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I have received a kidney transplant from a living or deceased donor.

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My donor for the transplant is a match according to specific blood tests.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Percentage of patients with biopsy-proven acute rejection at 12 months

Secondary outcome measures

Estimated glomerular filtration rate (eGFR)

Number of de novo donor-specific antibodies

Number of persistent pre-existing donor-specific antibodies

+2 more

Side effects data

From 2022 Phase 4 trial • 97 Patients • NCT03020589

98%

Anemia

83%

Hypomagnesemia

75%

Leukopenia

70%

Hyperkalemia

57%

Abnormal renal function

50%

Hypophosphatemia

50%

Increase creatinine

45%

Hyperglycemia

33%

Delayed Graft Function Requiring Dialysis

30%

Diarrhea

30%

Nausea

28%

Headache

28%

Hypertension

25%

Tremor

25%

Infection

23%

Constipation

23%

Edema

20%

Vomiting

18%

Hyperlipidemia

18%

Hypokalemia

10%

Biopsy Proven Acute Rejection

Neurotoxicity

Graft loss

100%

80%

60%

40%

20%

Study treatment Arm

CYP3A5 Based Tacrolimus Dosing

Control

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Extended-release tacrolimusExperimental Treatment1 Intervention

Kidney transplant recipients will receive extended-release tacrolimus in addition to standard-dose mycophenolate and prednisone for maintenance immunosuppression.

Group II: Immediate-release tacrolimusActive Control1 Intervention

Kidney transplant recipients will receive immediate-release tacrolimus in addition to standard-dose mycophenolate and prednisone for maintenance immunosuppression.

0 / 5Eligibility criteria met