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Immunosuppressant

Tacrolimus Regimens for Kidney Transplant Complications (PTAAK Trial)

Phase 4

Recruiting

Led By Roy D Bloom, MD

Research Sponsored by Roy D. Bloom, MD

Eligibility Criteria Checklist

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

Must have

Subjects whose concurrent immunosuppression at the time of transplant will be (generic or brand formulation) Mycophenolate mofetil (MMF, CellCept) or mycophenolic sodium (MPS, Myfortic®), either a standard prenisone taper or an early withdrawal protocol, and induction with rabbit-antithymocyte globulin (Thymoglobulin®)

Subjects receiving a first or second deceased donor or living donor kidney transplant at the Hospital of the University of Pennsylvania

Must not have

Subjects who have underwent gastric bypass at any time pre transplant

Subjects with severe diabetic gastroparesis or other severe GI disturbances that could interfere with Tacrolimus absorption

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is comparing two different tacrolimus regimens in kidney transplant patients to see which is more effective and safe.

Who is the study for?

This trial is for African American individuals with a BMI ≥19, undergoing their first or second kidney transplant. They must be using certain immunosuppressants and can have Hepatitis B or C. Excluded are those with severe GI issues affecting drug absorption, HIV positive, poor medical adherence history, women not using contraception unless exempted by specific criteria, anyone over 75 years old, recipients of more than two kidney transplants, and those allergic to Tacrolimus.

What is being tested?

The study compares the effects on blood vessel function between two forms of the drug Tacrolimus: extended-release tablets taken once daily (Envarsus XR®) versus immediate-release capsules taken twice daily (Prograf®). It measures how well blood vessels respond to heartbeats before and after treatment in kidney transplant patients.

What are the potential side effects?

Tacrolimus may cause side effects such as tremors, high blood pressure, kidney problems, infections due to weakened immune system response from the medication. The risk of diabetes and gastrointestinal disturbances might also increase.

Eligibility Criteria

Inclusion Criteria

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

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I will be taking specific immunosuppressants and undergoing a certain treatment protocol after my transplant.

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I am getting my first or second kidney transplant from a living or deceased donor at the University of Pennsylvania Hospital.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a gastric bypass surgery before a transplant.

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I have severe stomach issues that could affect medication absorption.

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My condition is recurrent FSGS.

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I am over 75 years old.

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My partner is sterilized.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assess Change in Pulse Wave Velocity

Secondary study objectives

Assess Change in Pulse Wave Velocity measurements

Assess Change in Vascular Compliance

Assess Change in Vascular Compliance measurements

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Awards & Highlights

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.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Group I: Extended Release Tacrolimus TabletsActive Control1 Intervention

Dosed once daily in the morning and started at a dose of 0.14 mg/kg/day by the first day after kidney transplant (post-operative day 1). This medication will be given with rabbit antithymocyte globulin (rATG) induction, oral mycophenolate mofetil (MMF) and oral steroids to help prevent rejection. These medications will be ordered per standard of care both inpatient and outpatient.

Group II: Immediate Release Tacrolimus CapsulesActive Control1 Intervention

Dosed twice daily 12 hours apart and started at a dose of 0.1mg/kg/day by the first day after kidney transplant (post-operative day 1). This medication will be given with rabbit antithymocyte globulin (rATG) induction, oral mycophenolate mofetil (MMF) and oral steroids to help prevent rejection. These medications will be ordered per standard of care both inpatient and outpatient.

0 / 7Eligibility criteria met