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Evaluate Effects and Safety of Pre-load Myfortic® in Transplant Patients

Information source: University of Cincinnati
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Transplant Recipients

Intervention: mycophenolic acid (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Cincinnati

Official(s) and/or principal investigator(s):
Adele Shields, Pharm.D., Principal Investigator, Affiliation: University of Cincinnati

Summary

This study is specifically designed to determine whether the initiation of Myfortic 2 weeks prior to transplantation will enhance the therapeutic efficacy of Simulect induction therapy in low to moderate risk patients. Specifically, the addition of Myfortic pretransplant to Simulect induction will be compared to standard Myfortic therapy with Thymoglobulin induction starting at the time of transplant in kidney transplant recipients.

Clinical Details

Official title: A 12-month, Prospective, Randomized, Dual Center, Open Label Pilot Study to Evaluate the Safety and Efficacy of Myfortic (Mycophenolic Acid) Loading Regimens in Combination With Thymoglobulin [Anti-thymocyte Globulin (Rabbit)] or Simulect (Basiliximab) Induction and Prograf (Tacrolimus) in Early Corticosteroid Withdrawal

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Incidence of biopsy-confirmed acute rejection by Banff '97 Criteria (updated 2007) at 6 months

Secondary outcome: Severity of acute rejection by Banff '97 Criteria

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients capable of understanding the purposes and risks of the study.

- Patients who can give written informed consent, and who are willing and able to

participate in the full course of the study.

- Women of childbearing potential must have a negative serum pregnancy test within the

last 48 hours prior to receiving study medication.

- Women of childbearing potential must use two reliable forms of contraception

simultaneously, unless they are status post bilateral tubal ligation, bilateral oophorectomy, or hysterectomy. Effective contraception must be used before beginning study drug therapy, for the duration of the study and for 6 weeks following completion of the study. Exclusion Criteria:

- Patients who are recipients of a multiple organ transplant or if the patient

previously received and organ transplant.

- Patients who are recipients of A-B-O incompatible transplants, all

complement-dependent cytotoxicity (CDC) crossmatch positive transplants.

- Sensitized patients [most recent anti-Human Leukocyte Antigens (HLA) Class I panel

reactive antibody (PRA) ≥ 25% by a CDC-based assay].

- Recipient or donor is known to be seropositive for hepatitis C virus (HCV) or B virus

(HBV) except for hepatitis B surface antibody positive.

- Recipient or donor is known to be seropositive for human immunodeficiency virus

(HIV).

- Patient has uncontrolled concomitant infection or any other unstable medical

condition that could interfere with the study objectives.

- Patients with thrombocytopenia (<75,000/mm3 ), with an absolute neutrophil count of <

1,500/mm3); and/or leucopoenia (< 2,500/mm3), or anemia (hemoglobin < 6 g/dL) prior to study inclusion.

- Patient is taking or has been taking an investigational drug in the 30 days prior to

transplant.

- Patient has a known hypersensitivity to tacrolimus, mycophenolate mofetil,

enteric-coated mycophenolic acid, rabbit anti-thymocyte globulin, or corticosteroids.

- Patients with severe diarrhea or other gastrointestinal disorders that might

interfere with their ability to absorb oral medication; diabetic patients with previously diagnosed diabetic gastroenteropathy, or patients with active peptic ulcer disease.

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

- Patients with a history of malignancy within the last five years, except for

successfully excised squamous or basal cell carcinoma of the skin.

- Patient is pregnant or lactating, 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.

- 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.

- Inability to cooperate or communicate with the investigator.

Locations and Contacts

University of Cincinnati Medical Center, Cincinnati, Ohio 45267, United States
Additional Information

Starting date: September 2010
Last updated: May 29, 2014

Page last updated: August 23, 2015

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