Veloxis de Novo Kidney Transplant ECSWD

NCT03828682 | Unknown Phase 4 FDA Drug

• 1 other identifier: 2018-7742
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

This study is designed to evaluate the safety and efficacy of LCPT in combination with rATG, mycophenolate and early corticosteroid withdrawal (CSWD) in de novo kidney transplant recipients.

Conditions

Kidney Transplantation; Immunosuppression

Keywords

tacrolimus; extended release; kidney transplantation; steroid withdrawal; once daily

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with the combination oral outcome of Biopsy-proven acute rejection, patient death and graft loss

  Biopsy-proven acute rejection, patient death and graft loss

  12 months

Study Arms (2)

Prospective Arm

EXPERIMENTAL

De novo kidney transplant recipients receiving: rabbit antithymocyte globulin induction (1.5mg/kg, dosage range 4-6mg/kg total dose over 5-10 days) 5-day steroid withdrawal (methylprednisolone 500mg IV on day 1 (day of transplant), 250mg IV on day 2, 125mg IV on day 3, prednisone 80mg PO on day 4, 60mg PO on day 5 and then no more steroids Once-daily tacrolimus XR 0.8mg/kg/day started when or when serum creatinine is \<4mg/dL or by 48 hours of transplant to target 24-hr trough levels of 8-12ng/mL up to day 30 followed by 24-hour trough targets of 5-10ng/mL Mycophenolate mofetil (1000 mg PO BID) or mycophenolic acid (720mg PO BID) twice daily started prior to surgery

Drug: Tacrolimus Extended Release Oral Tablet [Envarsus]; Drug: Mycophenolate Mofetil; Drug: Mycophenolic Acid Oral Product; Drug: Methylprednisolone; Drug: Prednisone; Drug: Rabbit Anti-Human T-Lymphocyte Globulin Injectable Solution [Thymoglobulin]

Comparator arm

ACTIVE COMPARATOR

Historical control arm consisting of the following De novo kidney transplant recipients receiving: rabbit antithymocyte globulin induction (1.5mg/kg, dosage range 4-6mg/kg total dose over 5-10 days) 5-day steroid withdrawal (methylprednisolone 500mg IV on day 1 (day of transplant), 250mg IV on day 2, 125mg IV on day 3, prednisone 80mg PO on day 4, 60mg PO on day 5 and then no more steroids Twice-daily tacrolimus 0.1mg/kg/day started when or when serum creatinine is \<4mg/dL or by 48 hours of transplant to target 12-hr trough levels of 8-12ng/mL up to day 30 followed by 12-hour trough targets of 5-10ng/mL Mycophenolate mofetil (1000 mg PO BID) or mycophenolic acid (720mg PO BID) twice daily started prior to surgery

Drug: Mycophenolate Mofetil; Drug: Mycophenolic Acid Oral Product; Drug: Tacrolimus; Drug: Methylprednisolone; Drug: Prednisone; Drug: Rabbit Anti-Human T-Lymphocyte Globulin Injectable Solution [Thymoglobulin]

Interventions

Tacrolimus Extended Release Oral Tablet [Envarsus] DRUG

Tacrolimus Extended Release Oral Tablet \[Envarsus\]

Also known as: Envarsus XR

Prospective Arm

Mycophenolate Mofetil DRUG

Mycophenolate mofetil capsules or tablets

Also known as: Cellcept, MMF

Comparator arm; Prospective Arm

Mycophenolic Acid Oral Product DRUG

mycophenolic acid tablets

Also known as: Myfortic, MPA

Comparator arm; Prospective Arm

Tacrolimus DRUG

Twice daily tacrolimus

Also known as: Prograf, FK506

Comparator arm

Methylprednisolone DRUG

Methylprednisolone taper

Comparator arm; Prospective Arm

Prednisone DRUG

Prednisone taper

Also known as: Deltasone

Comparator arm; Prospective Arm

Rabbit Anti-Human T-Lymphocyte Globulin Injectable Solution [Thymoglobulin] DRUG

Rabbit Anti-Human T-Lymphocyte Globulin

Also known as: Thymoglobulin, rATG

Comparator arm; Prospective Arm

Eligibility Criteria

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

You may qualify if:

• Male and female patients ≥ 18 years of age.
• Patient who is receiving a renal transplant from a living or heart-beating deceased donor.
• The patient has given written informed consent to participate in the study

You may not qualify if:

• Patient has previously received an organ transplant other than a kidney.
• Patient is receiving an HLA identical living donor transplant.
• Patient who is a recipient of a multiple organ transplant.
• Patient has a most recent cytotoxic PRA of \>25% or calculated PRA \>50% where multiple moderate level HLA antibodies exist and in the opinion of the PI represents substantial HLA sensitization.
• Patient with a positive T or B cell crossmatch that is primarily due to HLA antibodies.
• Patient with a donor specific antibody (DSA) as deemed by the PI to be associated with significant risk of rejection.
• Patient has received an ABO incompatible donor kidney.
• The deceased donor and/or deceased donor kidney meet any of the following extended criteria for organ donation (ECD):
• Donor age ≥ 60 years OR
• Donor age 50-59 years and 1 of the following:
• i. Cerebrovascular accident (CVA) + hypertension + SCr \> 1.5 mg/dL OR ii. CVA + hypertension OR iii. CVA + SCr \> 1.5 mg/dL OR iv. Hypertension + SCr \> 1.5 mg/dL OR c. CIT ≥ 24 hours, donor age \> 10 years OR d. Donation after cardiac death (DCD)
• Recipients will be receiving a dual or en bloc kidney transplant.
• Donor anticipated cold ischemia is \>30hours.
• Recipient that is seropositive for hepatitis C virus (HCV) with detectable Hepatitis C viral load are excluded. HCV seropositive patients with a negative HCV viral load testing may be included.
• Recipients with a positive hepatitis B viral load or positive hepatitis B surface antigen testing within 1 year of consent.

Sponsors & Collaborators

• Simon Tremblay, PharmD, PhD: lead
• Veloxis Pharmaceuticals: collaborator

Study Sites (2)

The Christ Hospital

Cincinnati, Ohio, 45219, United States

RECRUITING

University of Cincinnati

Cincinnati, Ohio, 45267, United States

RECRUITING

MeSH Terms

Interventions

Tacrolimus; Mycophenolic Acid; Methylprednisolone; Prednisone; thymoglobulin

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols

Study Officials

• Simon Tremblay, PharmD, PhD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Tremblay, PharmD, PhD

CONTACT

513-558-9967; tremblsn@ucmail.uc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant Professor of Surgery

Model Details: A prospective cohort of de novo kidney transplant recipients will be assigned to treatment group and compared to historical controls

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: February 4, 2019
• Study Start: June 21, 2019
• Primary Completion: July 31, 2021
• Study Completion: June 30, 2022
• Last Updated: May 13, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)