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Evaluation of Anti-rejection Drug, Tacrolimus, in African-Americans With Kidney Transplant

Primary Purpose

Kidney Disease, End-Stage, Donor Specific Antibodies, Acute Rejection of Renal Transplant

Status

Withdrawn

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Envarsus XR

About this trial

This is an interventional treatment trial for Kidney Disease, End-Stage focused on measuring Renal Transplant, Donor Specific Antibodies, African American, Acute Rejection of Renal Transplant, Kidney Transplant, End Stage Renal Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

• Primary live donor or deceased donor renal allograft
- African American patients aged 18 to 65 years
- Ability to take oral medications
- Not currently on medications known to significantly interfere with tacrolimus metabolism, e.g. strong CYP3A4 inducers or inhibitors including but not limited to rifampin, rifabutin, phenytoin, carbamazepine, phenobarbital, protease inhibitors, azole antifungal (voriconazole, itraconazole, posaconazole, ketoconazole)
  o Note: All patients will be discharged on clotrimazole 10 mg three times daily for one month for thrush prophylaxis, a known mild-to-moderate CYP3A4 inhibitor
- Female subjects of childbearing potential:
  - Not current pregnant
  - Agree not to try to become pregnant during the study period
  - Agree to consistently use two forms of highly effective birth control throughout the study period
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

• Presence of a positive T- or B-cell flow cytometry allogeneic crossmatch
- Presence of pre-formed anti-human leukocyte antigen (HLA) donor-specific antibodies (DSAs)
- Recipient of an ABO-incompatible organ
- Receipt of a multi-organ or dual kidney transplant
- Receipt of pediatric en bloc deceased donor kidneys
- Receipt of deceased donor kidney with a kidney donor profile index (KDPI) greater than or equal to 85%
- Has undergone desensitization, or received antibody removal, anti-B-cell, or anti-plasma cell therapy in the 90 days preceding the transplant
- Planned initiation of antibody removal (i.e. plasmapheresis) within 7 days of the transplant procedure
- Positive test for latent tuberculosis (TB) and has not previously received adequate anti-microbial therapy or would require TB prophylaxis after transplant
- Uncontrolled concomitant infection that would not allow for targeting escalated tacrolimus trough concentrations, as deemed by prescriber
- Known infection or seropositivity for hepatitis B virus (HBV, defined by positive HBsAg, anti-HBcAg, or positive viral load) or hepatitis C virus (HCV) with active viral load
- Current malignancy
- Use of an investigational study in the 30 days prior to the transplant procedure

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Arm Label

Group 1 - Low-Intensity

Group 1 - Moderate-Intensity

Group 1 - High-Intensity

Group 2 - Low-Intensity

Group 2 - Moderate-Intensity

Group 2 - High-Intensity

Arm Description

All patients will receive standard induction immunosuppression according to institution protocol. TAC will be started when clinically appropriate according to institution protocol. TAC dosing will be 2 mg twice daily to be reduced by 20% after week 1 and start Envarsus XR once daily. Target Tacrolimus Trough Concentrations: Week 0 to Week 4: 8-10 mg/mL Month 1 to Month 3: 6-8 mg/mL

All patients will receive standard induction immunosuppression according to institution protocol. TAC will be started when clinically appropriate according to institution protocol. TAC dosing will be 3 mg twice daily to be reduced by 20% after week 1 and start Envarsus XR once daily. Target Tacrolimus Trough Concentrations: Week 0 to Week 4: 10-12 mg/mL Month 1 to Month 3: 8-10 mg/mL

All patients will receive standard induction immunosuppression according to institution protocol. TAC will be started when clinically appropriate according to institution protocol. TAC dosing will be 4 mg twice daily to be reduced by 20% after week 1 and start Envarsus XR once daily. Target Tacrolimus Trough Concentrations: Week 0 to Week 4: 12-14 mg/mL Month 1 to Month 3: 10-12 mg/mL

All patients will receive standard induction immunosuppression according to institution protocol. TAC will be started when clinically appropriate according to institution protocol. TAC dosing will be 3 mg twice daily to be reduced by 20% after week 1 and start Envarsus XR once daily. Target Tacrolimus Trough Concentrations: Week 0 to Week 4: 10-12 mg/mL Month 1 to Month 3: 8-10 mg/mL

All patients will receive standard induction immunosuppression according to institution protocol. TAC will be started when clinically appropriate according to institution protocol. TAC dosing will be 4 mg twice daily to be reduced by 20% after week 1 and start Envarsus XR once daily. Target Tacrolimus Trough Concentrations: Week 0 to Week 4: 12-14 mg/mL Month 1 to Month 3: 10-12 mg/mL

Outcomes

Primary Outcome Measures

Number of participants reaching the composite endpoint

Composite endpoint of freedom from all of the following: i) biopsy-proven T-cell mediated rejection Banff Grade ≥1A, ii) antibody-mediated rejection, iii) de novo DSA, or iv) immune-mediated graft loss. The endpoint is a binary endpoint (Yes or No) of the composite of all 4 potential outcomes. The presence of any one of the four possible outcomes will be counted as a No for the binary endpoint (no freedom from the composite endpoint). The absence of all 4 possible outcomes will be counted as Yes for freedom from all of the possible outcomes.

Secondary Outcome Measures

Proportion of subjects experiencing nephrotoxicity during the study

Increase in serum creatinine of ≥0.3mg/dL

Proportion of subjects experiencing neurotoxicity during the study

Clinical intolerability including headache or significant tremors that resolve with reduction of the dose of Envarsus

Proportion of subjects experiencing infectious complications during the study

Participants requiring extended (>2 weeks) reduction in dose of Envarsus due to BK-polyomavirus or cytomegalovirus viral loads at 1, 3, and 6 months post-transplant

Difference in estimated glomerular filtration rate at 1, 3, and 6 months between groups of enrolled subjects

Assessed as the Chronic Kidney Disease - Epidemiology Collaboration equation

Difference in immunosuppressant side effects between enrolled subjects

Assessed using the "Immunosuppressant Side Effects Instrument - The Memphis Survey" questionnaire

Enrolled subject overall survival and Graft survival at 6 months

Freedom from death and from graft loss at 6 months

Full Information

NCT ID

NCT04665310

First Posted

April 2, 2019

Last Updated

December 10, 2020

Sponsor

The Methodist Hospital Research Institute

Collaborators

Veloxis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT04665310

Brief Title

Evaluation of Anti-rejection Drug, Tacrolimus, in African-Americans With Kidney Transplant

Official Title

Evaluation of Early Dose Escalation Using Extended-Release Tacrolimus (Envarsus XR®) to Reduce Acute Rejection and Donor Specific Antibodies in African American Renal Transplant Recipients

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Withdrawn

Why Stopped

Study not started, funding

Study Start Date

September 1, 2018 (Actual)

Primary Completion Date

October 31, 2020 (Anticipated)

Study Completion Date

October 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Methodist Hospital Research Institute

Collaborators

Veloxis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

In spite of conventional immunosuppression with lymphocyte-depleting induction followed by tacrolimus- and mycophenolate-based regimens, African American (AA) renal transplant recipients experience higher rates of acute rejection (AR), donor specific antibodies (DSA), and graft failure. Envarsus Extended-Release (XR)® (ENV) is a novel extended-release formulation of tacrolimus with a favorable pharmacokinetic profile, even in the setting of CYP3A5*1 allele (rapid metabolizers). The investigator will evaluate the safety and efficacy of early dose escalation with ENV in AA recipients. The study hypothesis is that higher tacrolimus target concentrations may be achieved without typical dose-limiting toxicities, and this may ultimately result in lower incidence of early AR, DSA, and graft loss.

Detailed Description

Phase 4 (post-marketing) De novo African American living or deceased donor renal transplant recipients 18 to 65 years of age Number of subjects to be enrolled: 60 All patients will receive standard induction immunosuppression according to institution protocol. Within one week of transplantation, all patients will be converted from immediate-release tacrolimus (TAC) to extended-release tacrolimus (ENV) at 20% reduction in total daily dosage. Patients will be randomized to low-, moderate-, or high-intensity ENV groups, stratified by peak panel reactive antibody (pPRA) greater than or equal to 75%. Target tacrolimus trough concentrations for the first month post-transplant will be 8-10 ng/mL in low-intensity group, 10-12 ng/mL in moderate-intensity group, and 12-14 ng/mL in high-intensity group; likewise from month 1-3 post-transplant, target trough concentrations will be 6-8 ng/mL, 8-10 ng/mL, and 10-12 ng/mL, respectively. Subjects experiencing dose-limiting adverse events (AEs) will be de-escalated as warranted. Following month 3, all patients will be maintained on ENV at target tacrolimus trough concentrations according to institution protocol. Additional maintenance immunosuppression will consist of mycophenolate mofetil (MMF) at a goal dose of 2000 mg daily along with an oral prednisone taper to 5-10 mg daily by the end of month 1. All patients will be followed for 6 months post-transplant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Disease, End-Stage, Donor Specific Antibodies, Acute Rejection of Renal Transplant

Keywords

Renal Transplant, Donor Specific Antibodies, African American, Acute Rejection of Renal Transplant, Kidney Transplant, End Stage Renal Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Parallel Group - Dose Escalation with 2 groups stratified by pPRA <75% and >75% and then randomized into 3 Intensity Arms (Low, Moderate and High) based on dosing of Envarsus XR.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1 - Low-Intensity

Arm Type

Active Comparator

Arm Description

Arm Title

Group 1 - Moderate-Intensity

Arm Type

Active Comparator

Arm Description

All patients will receive standard induction immunosuppression according to institution protocol. TAC will be started when clinically appropriate according to institution protocol. TAC dosing will be 3 mg twice daily to be reduced by 20% after week 1 and start Envarsus XR once daily. Target Tacrolimus Trough Concentrations: Week 0 to Week 4: 10-12 mg/mL Month 1 to Month 3: 8-10 mg/mL

Arm Title

Group 1 - High-Intensity

Arm Type

Active Comparator

Arm Description

All patients will receive standard induction immunosuppression according to institution protocol. TAC will be started when clinically appropriate according to institution protocol. TAC dosing will be 4 mg twice daily to be reduced by 20% after week 1 and start Envarsus XR once daily. Target Tacrolimus Trough Concentrations: Week 0 to Week 4: 12-14 mg/mL Month 1 to Month 3: 10-12 mg/mL

Arm Title

Group 2 - Low-Intensity

Arm Type

Active Comparator

Arm Description

Arm Title

Group 2 - Moderate-Intensity

Arm Type

Active Comparator

Arm Description

All patients will receive standard induction immunosuppression according to institution protocol. TAC will be started when clinically appropriate according to institution protocol. TAC dosing will be 3 mg twice daily to be reduced by 20% after week 1 and start Envarsus XR once daily. Target Tacrolimus Trough Concentrations: Week 0 to Week 4: 10-12 mg/mL Month 1 to Month 3: 8-10 mg/mL

Arm Title

Group 2 - High-Intensity

Arm Type

Active Comparator

Arm Description

All patients will receive standard induction immunosuppression according to institution protocol. TAC will be started when clinically appropriate according to institution protocol. TAC dosing will be 4 mg twice daily to be reduced by 20% after week 1 and start Envarsus XR once daily. Target Tacrolimus Trough Concentrations: Week 0 to Week 4: 12-14 mg/mL Month 1 to Month 3: 10-12 mg/mL

Intervention Type

Drug

Intervention Name(s)

Envarsus XR

Other Intervention Name(s)

Life Cycle Pharma (LCP)-tacrolimus, once-daily extended-release tacrolimus, once-daily prolonged-release tacrolimus, Tacrolimus-LCP

Intervention Description

tacrolimus, extended-release tablets, a calcineurin inhibitor

Primary Outcome Measure Information:

Title

Number of participants reaching the composite endpoint

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Proportion of subjects experiencing nephrotoxicity during the study

Description

Increase in serum creatinine of ≥0.3mg/dL

Time Frame

6 months

Title

Proportion of subjects experiencing neurotoxicity during the study

Description

Clinical intolerability including headache or significant tremors that resolve with reduction of the dose of Envarsus

Time Frame

6 months

Title

Proportion of subjects experiencing infectious complications during the study

Description

Participants requiring extended (>2 weeks) reduction in dose of Envarsus due to BK-polyomavirus or cytomegalovirus viral loads at 1, 3, and 6 months post-transplant

Time Frame

6 months

Title

Difference in estimated glomerular filtration rate at 1, 3, and 6 months between groups of enrolled subjects

Description

Assessed as the Chronic Kidney Disease - Epidemiology Collaboration equation

Time Frame

6 months

Title

Difference in immunosuppressant side effects between enrolled subjects

Description

Assessed using the "Immunosuppressant Side Effects Instrument - The Memphis Survey" questionnaire

Time Frame

6 months

Title

Enrolled subject overall survival and Graft survival at 6 months

Description

Freedom from death and from graft loss at 6 months

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: • Primary live donor or deceased donor renal allograft African American patients aged 18 to 65 years Ability to take oral medications Not currently on medications known to significantly interfere with tacrolimus metabolism, e.g. strong CYP3A4 inducers or inhibitors including but not limited to rifampin, rifabutin, phenytoin, carbamazepine, phenobarbital, protease inhibitors, azole antifungal (voriconazole, itraconazole, posaconazole, ketoconazole) o Note: All patients will be discharged on clotrimazole 10 mg three times daily for one month for thrush prophylaxis, a known mild-to-moderate CYP3A4 inhibitor Female subjects of childbearing potential: Not current pregnant Agree not to try to become pregnant during the study period Agree to consistently use two forms of highly effective birth control throughout the study period Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Exclusion Criteria: • Presence of a positive T- or B-cell flow cytometry allogeneic crossmatch Presence of pre-formed anti-human leukocyte antigen (HLA) donor-specific antibodies (DSAs) Recipient of an ABO-incompatible organ Receipt of a multi-organ or dual kidney transplant Receipt of pediatric en bloc deceased donor kidneys Receipt of deceased donor kidney with a kidney donor profile index (KDPI) greater than or equal to 85% Has undergone desensitization, or received antibody removal, anti-B-cell, or anti-plasma cell therapy in the 90 days preceding the transplant Planned initiation of antibody removal (i.e. plasmapheresis) within 7 days of the transplant procedure Positive test for latent tuberculosis (TB) and has not previously received adequate anti-microbial therapy or would require TB prophylaxis after transplant Uncontrolled concomitant infection that would not allow for targeting escalated tacrolimus trough concentrations, as deemed by prescriber Known infection or seropositivity for hepatitis B virus (HBV, defined by positive HBsAg, anti-HBcAg, or positive viral load) or hepatitis C virus (HCV) with active viral load Current malignancy Use of an investigational study in the 30 days prior to the transplant procedure

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed O Gaber, MD

Organizational Affiliation

Houston Methodist Physicians Organization

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

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Evaluation of Anti-rejection Drug, Tacrolimus, in African-Americans With Kidney Transplant

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