Pulse Wave Velocity, Tacrolimus Time in Therapeutic Range and CV in African American Kidney Transplants

NCT03841097 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 832046
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to evaluate the pulse wave velocity and vascular compliance measurements at the beginning and the end of the study while the participants are taking either extended release tacrolimus tablets (known by brand name Envarsus XR®, and also referred to as LCPT in this study) given once-daily each morning after transplantation or immediate release tacrolimus capsules (also known by brand name Prograf® or abbreviation IR-TAC in this study) that are administered twice-daily 12 hours apart after kidney transplantation. Pulse wave velocity and vascular compliance measurements are two non-invasive tests that are used to evaluate how well the blood vessels adapt to each heartbeat. The secondary purpose is to look at the effectiveness and safety of LCPT given once-daily compared to IR-TAC given twice-daily 12 hours apart after kidney transplantation.

Conditions

Kidney Transplant; Complications

Keywords

Renal; Transplant; Pulse wave velocity

Outcome Measures

Primary Outcomes (3)

• Assess Change in Pulse Wave Velocity

  To assess the change in PWV measurements (m/sec) from baseline to 12-24 months after transplant in kidney recipient subjects on LCPT compared to those on IR-Tac.

  baseline and months 12-24 post transplant

• Assess Change in Vascular Compliance measurements

  To assess the change in vascular compliance using central blood pressure (mmHg) from baseline to 12-24 months after transplant in kidney recipient subjects on LCPT compared to those on IR-Tac.

  baseline and months 12-24 post transplant

• Assess Change in Vascular Compliance

  To assess the change in vascular compliance using Augmentation Index (ratio) from baseline to 12 -24 months after transplant in kidney recipient subjects on LCPT compared to those on IR-Tac.

  baseline and months 12-24 post transplant

Secondary Outcomes (15)

• Assess Change in Pulse Wave Velocity measurements

  baseline and 1 month post transplant

• Assess Change in Vascular Compliance measurements

  baseline and 1 month post transplant

• Assess Change in Vascular Compliance

  baseline and 1 month post transplant

• Compare Percent of Kidney Recipients with Tacrolimus Time in Therapeutic Range

  1 year

• Compare the variability of Tacrolimus levels between LCPT and IR-Tac

  First 12-24 months

Study Arms (2)

Extended Release Tacrolimus Tablets

ACTIVE COMPARATOR

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.

Drug: Extended Release Tacrolimus Tablets

Immediate Release Tacrolimus Capsules

ACTIVE COMPARATOR

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.

Drug: Immediate Release Tacrolimus Capsule

Interventions

Extended Release Tacrolimus Tablets DRUG

The primary objective is to assess the change in pulse wave velocity (PWV) and vascular compliance measurements from baseline to 12-24 months after transplant in kidney recipient subjects on LCPT compared to those on IR-Tac.

Also known as: LCPT, Envarsus XR®

Extended Release Tacrolimus Tablets

Immediate Release Tacrolimus Capsule DRUG

The primary objective is to assess the change in pulse wave velocity (PWV) and vascular compliance measurements from baseline to 12-24 months after transplant in kidney recipient subjects on LCPT compared to those on IR-Tac.

Also known as: IR-TAC, Prograf®

Immediate Release Tacrolimus Capsules

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who self-report their race/ethnicity as Black-non-Hispanic only (which may include self-reported African ancestry as African-American, Afro-Caribbean or African)
• Subjects receiving a first or second deceased donor or living donor kidney transplant at the Hospital of the University of Pennsylvania
• Subjects whose body mass index (BMI) ≥19
• Subjects who are sero-positive for Hepatitis B or C positive may also be enrolled.
• 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®).

You may not qualify if:

• Subjects who are greater than 75 years old
• Known hypersensitivity to Tacrolimus and hydrogenated castor oil
• Subjects who are not self-described as being of Black African descent and living in the United States
• Subjects who self-report their race/ethnicity as Black-Hispanic or Multiracial
• Subjects who are recipients of organ transplants other than kidney
• Subjects who are recipients of third time or more kidney transplants
• Subjects who are HIV positive at the time of pre-transplant screening
• Subjects with recurrent focal segmental glomerulosclerosis (FSGS)
• Subjects with any severe medical condition (including infection or severe liver disease) requiring acute or chronic treatment that in the investigator's opinion would interfere with study participation
• Subjects with WBC ≤ 2000/mm3 or ANC ≤ 1500 mm3 with PLT ≤ 75,000/mm3 or HGB \< 8 g/dL
• Subjects with mental or physical conditions or known non-adherence (defined as documentation in the patient chart of multiple missed visits and/or medication doses) which in the investigator's opinion would interfere with the objectives of the study
• Subjects who have been exposed to investigational therapy within 30 days prior to enrollment or five half-lives of the investigational product (whichever is greater).
• Subjects with severe diabetic gastroparesis or other severe GI disturbances that could interfere with Tacrolimus absorption
• Subjects who have underwent gastric bypass at any time pre transplant.
• Pregnant or nursing (lactating) women subjects, where pregnancy is defined as a state of female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\> 5 mIU/ml).

Sponsors & Collaborators

• Roy D. Bloom, MD: lead
• Veloxis Pharmaceuticals: collaborator

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Roy D Bloom, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Professor of Medicine, and Medical Director of the Penn Kidney Transplant Program

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: February 15, 2019
• Study Start: November 11, 2019
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (1)