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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

PTAAK 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.Check my eligibility

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.See study design

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.

PTAAK Trial 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.

PTAAK Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assess Change in Pulse Wave Velocity

Secondary outcome measures

Assess Change in Pulse Wave Velocity measurements

Assess Change in Vascular Compliance

Assess Change in Vascular Compliance measurements

+12 more

PTAAK 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 / 2Eligibility criteria met

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Who is running the clinical trial?

Roy D. Bloom, MDLead Sponsor

Veloxis PharmaceuticalsIndustry Sponsor

41 Previous Clinical Trials

3,086 Total Patients Enrolled

Roy D Bloom, MDPrincipal InvestigatorUniversity of Pennsylvania

Media Library

Extended Release Tacrolimus Tablets (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT03841097 — Phase 4

Frequently Asked Questions

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

Does Extended Release Tacrolimus Tablets pose any health risks to patients?

"With evidence suggesting that Extended Release Tacrolimus Tablets are a safe and approved treatment, the safety score has been assigned as 3."

Answered by AI

What condition is Extended Release Tacrolimus Tablets employed to treat?

"Extended Release Tacrolimus Tablets are a common treatment for atopic dermatitis, as well as rejection in liver and kidney transplants. This medication can also help mitigate psoriasis symptoms."

Answered by AI

What type of individuals are ideal participants for this experiment?

"This trial is accepting 60 participants of age 18 to 75 who have undergone kidney transplantation. Notably, the requisite qualifications for applicants are as follows: Transplanted at University of Pennsylvania Hospital; immunosuppression with Mycophenolate mofetil (MMF/CellCept®) or mycophenolic sodium (MPS/Myfortic®), prednisone and induction with rabbit-antithymocyte globulin (Thymoglobulin®)."

Answered by AI

How many patients are participating in this therapeutic experiment?

"Affirmative. The information hosted on clinicaltrials.gov corroborates that the specified medical trial is currently enlisting participants; it was first posted in November 11th 2019 and updated most recently on February 2nd 2022, seeking 60 patients from one site."

Answered by AI

Are there any vacancies to participate in this scientific experiment?

"Data on clinicaltrials.gov attests that this medical trial is currently enlisting participants, having been originally posted on November 11th 2019 and most recently updated on February 2nd 2022."

Answered by AI

Is there precedent for utilizing Extended Release Tacrolimus Tablets in research experiments?

"At present, 150 clinical trials are underway to examine Extended Release Tacrolimus Tablets. Of those, 18 have advanced to the third stage of testing. Most research into this medication is being conducted in Nashville, Tennessee but 871 locations across the nation provide access to these studies."

Answered by AI