Clinical trial NCT01336296: Evaluate Effects and Safety of Pre-load Myfortic® in Transplant Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplant Recipients
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2011-04-15
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Incidence of Biopsy-confirmed Acute Rejection by Banff '97 Criteria (Updated 2007) 3, 6 and 12 Months Post Transplant
timeFrame: 3, 6 and 12 months post transplant
Secondary outcomes:
measure: Severity of Acute Rejection by Banff '97 Criteria
timeFrame: Severity 1 year post transplant
measure: Difference in Renal Function
timeFrame: Difference at 1 month, 3 months, 6 months, 1 year
measure: Incidence of Chronic Alloantibody Rejection or Chronic Allograft Arteriopathy by Banff '97
timeFrame: 1 year
measure: Number of Patients Requiring Anti-lymphocyte Therapy for Acute Rejection
timeFrame: 1 year
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Adele Shields, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References: