Extended Release Tacrolimus vs. Twice-Daily Tacrolimus

NCT03289650 | Completed Phase 3 Results FDA Drug

• 1 other identifier: STU00205327
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of the study is to prospectively investigate the impact of two maintenance calcineurin inhibitor immunosuppressive regimens: once-daily extended release tacrolimus and twice-daily tacrolimus on subpopulations of T and B cells and alloreactive T cells as well as on renal allograft function.

Conditions

End Stage Renal Disease; Rejection of Renal Transplant

Keywords

immunosuppression

Outcome Measures

Primary Outcomes (1)

• Change in Kidney Transplant Function From 2 Weeks Post Transplant Through 12 Months Post Transplant

  change in the mean eGFR from the baseline (2 weeks post transplant), 3 months (post transplant) , and 12 months (post transplant).

  2 weeks post transplant through 12 months post transplant

Secondary Outcomes (5)

• Change in Subpopulations of T Cells From 2 Weeks Post Transplant Through 12 Months Post Transplant

  Measured at 2 weeks post transplant, 3 months post transplant, 12 months post transplant

• Number of Participants With Acute Rejection at 3 Months and 12 Months Post-Transplant

  Measured at 3 months post transplant, 12 months post transplant

• Number of Participants With Graft Loss at 3 Months and 12 Months Post-Transplant

  Measured at 3 months post transplant, 12 months post transplant

• Number of Subjects Deceased at at 3 Months and 12 Months Post-Transplant

  Through 12 months post transplant

• Number of Participants With Change in Allograft Immunohistopathology Profile

  Measured at 3 months post transplant, 12 months post transplant

Study Arms (2)

Standard of care tacrolimus twice-daily

ACTIVE COMPARATOR

Drug: Tacrolimus

Extended-release tacrolimus once-daily

ACTIVE COMPARATOR

Drug: Tacrolimus Extended Release Oral Tablet [Envarsus]

Interventions

Tacrolimus DRUG

immunosuppressive agent tacrolimus, given twice-daily

Standard of care tacrolimus twice-daily

Tacrolimus Extended Release Oral Tablet [Envarsus] DRUG

immunosuppressive agent extended-release tacrolimus, given once daily

Also known as: LCP-tacro

Extended-release tacrolimus once-daily

Eligibility Criteria

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

You may qualify if:

• \. Patients who are males or females aged 18-65 years. 2. Use of the following induction medications: basiliximab and rituximab. 2. Donors aged 18-65 years. 3. No prior organ transplant 4. Patients who are single-organ recipients (kidney only). 5. Women who are of childbearing potential must have a negative serum pregnancy test before transplantation and agree to use a medically acceptable method of contraception throughout the treatment period.
• \. Subject (recipient) is able to understand the consent form and give written informed consent

You may not qualify if:

• Delayed graft function (please see above).
• Known sensitivity or contraindication to alemtuzumab, Envarsus® XR, tacrolimus or MMF.
• Use of the following induction medications: basiliximab and rituximab
• Patient with significant or active infection.
• Patients with a positive flow cytometric crossmatch using donor lymphocytes and recipient serum.
• Patients with PRA \> 40%
• Patients with current or historic donor specific antibodies
• Body Mass Index (BMI) of \< 18 or \> 35
• Patients who are pregnant or nursing mothers.
• Patients whose life expectancy is severely limited by diseases other than renal disease.
• Ongoing active substance abuse, drug or alcohol.
• Major ongoing psychiatric illness or recent history of noncompliance.
• Significant cardiovascular disease (e.g.):
• Significant non-correctable coronary artery disease;
• Ejection fraction below 30%;

Sponsors & Collaborators

• Lorenzo Gallon: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Limitations and Caveats

The study ran out of funding and as a result the outcome (Change in Subpopulations of T Cells) has not been analyzed. The PI will look for additional funding to complete the analysis

Results Point of Contact

• Title: Lorenzo Gallon
• Organization: Northwestern University

l-gallon@northwestern.edu

312 695 4457

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: September 21, 2017
• Study Start: September 5, 2017
• Primary Completion: February 23, 2021
• Study Completion: February 23, 2021
• Last Updated: April 10, 2023
• Results First Posted: April 10, 2023

Record last verified: 2023-03

Locations

US (1)