Veloxis de Novo Kidney Transplant ECSWD

Kidney Transplantation Clinical Trial

Official title:

A 12-Month, Open Label Study of Extended Release Tacrolimus (Envarsus XR®, LCPT) With Mycophenolate, Rabbit Antithymocyte Globulin (rATG) and Early Steroid Withdrawal in de Novo Kidney Transplant Recipients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03828682
• Other study ID #: 2018-7742
• Status: Recruiting
• Phase: Phase 4
• Start date: June 21, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: May 2020
• Source: University of Cincinnati
• Contact: Simon Tremblay, PharmD, PhD
• Phone: 513-558-9967
• Email: tremblsn[@]ucmail.uc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2022
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male and female patients = 18 years of age.

2. Patient who is receiving a renal transplant from a living or heart-beating deceased donor.

3. Female patients of child bearing potential must have a negative urine or serum pregnancy test within the past 48 hours prior to study inclusion.

4. The patient has given written informed consent to participate in the study

Exclusion Criteria:

1. Patient has previously received an organ transplant other than a kidney.

2. Patient is receiving an HLA identical living donor transplant.

3. Patient who is a recipient of a multiple organ transplant.

4. 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.

5. Patient with a positive T or B cell crossmatch that is primarily due to HLA antibodies.

6. Patient with a donor specific antibody (DSA) as deemed by the PI to be associated with significant risk of rejection.

7. Patient has received an ABO incompatible donor kidney.

8. The deceased donor and/or deceased donor kidney meet any of the following extended criteria for organ donation (ECD):

1. Donor age = 60 years OR

2. 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)

9. Recipients will be receiving a dual or en bloc kidney transplant.

10. Donor anticipated cold ischemia is >30hours.

11. 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.

12. Recipients with a positive hepatitis B viral load or positive hepatitis B surface antigen testing within 1 year of consent.

13. Hepatitis B surface antibody negative recipients receiving a kidney from a donor seropositive for hepatitis B core antibody or hepatitis B nucleic acid.

14. Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV).

15. Recipient who is seronegative for Epstein Barr Virus (EBV)

16. Patient has uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives.

17. Patients with thrombocytopenia (PLT <75,000/mm3), and/or leukopenia (WBC < 2,000/mm3), or anemia (hemoglobin < 6 g/dL) prior to study inclusion.

18. Patient is taking or has been taking an investigational drug in the 30 days prior to transplant.

19. Patient who has undergone desensitization therapy within 6 months prior to transplant.

20. Patient has a known hypersensitivity to tacrolimus, mycophenolate mofetil/mycophenolic acid, rabbit anti-thymocyte globulin, or glucocorticoids.

21. Patient is receiving chronic steroid therapy at the time of transplant.

22. Patients with a history of cancer (other than non-melanoma skin cell cancers cured by local resection) within the last 5 years, unless they have an expected disease free survival of >95%.

23. Patient is pregnant, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by positive human Chorionic Gonadotropin (hCG) laboratory test.

24. Women of childbearing potential must use reliable contraception simultaneously, unless they are status post bilateral tubal ligation, bilateral oophorectomy, or hysterectomy.

25. Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator.

26. Inability to cooperate or communicate with the investigator.

27. Renal allograft has been reperfused for more than 48 hours at the time of enrollment

28. Patient unable to receive intact LCPT formulation

Related Conditions & MeSH terms

• Immunosuppression
• Kidney Transplantation

Intervention

Drug:
• Tacrolimus Extended Release Oral Tablet [Envarsus]
Tacrolimus Extended Release Oral Tablet [Envarsus]
• Mycophenolate Mofetil
Mycophenolate mofetil capsules or tablets
• Mycophenolic Acid Oral Product
mycophenolic acid tablets
• Tacrolimus
Twice daily tacrolimus
• Methylprednisolone
Methylprednisolone taper
• Prednisone
Prednisone taper
• Rabbit Anti-Human T-Lymphocyte Globulin Injectable Solution [Thymoglobulin]
Rabbit Anti-Human T-Lymphocyte Globulin

Locations

Country	Name	City	State
United States	The Christ Hospital	Cincinnati	Ohio
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Simon Tremblay, PharmD, PhD	Veloxis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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