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

Kidney Transplant Recipients Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01336296
• Other study ID #: Myfortic Preload
• Status: Completed
• Phase: Phase 4
• First received: October 28, 2010
• Last updated: May 29, 2014
• Start date: September 2010
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Kidney Transplant Recipients

Intervention

Drug:
• mycophenolic acid
Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant

Locations

Country	Name	City	State
United States	University of Cincinnati Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of biopsy-confirmed acute rejection by Banff '97 Criteria (updated 2007) at 6 months	Incidence of biopsy-confirmed acute rejection by Banff '97 Criteria (updated 2007) at 6 months.	6 months	No
Secondary	Severity of acute rejection by Banff '97 Criteria	Severity of acute rejection by Banff '97 Criteria. Acute cellular rejection Acute antibody mediated (humoral) rejection Proportion of patients requiring anti-lymphocyte therapy for acute rejection Incidence of chronic alloantibody rejection or chronic allograft arteriopathy by Banff '97 Criteria Change in creatinine clearance Urinary protein Incidence of denovo donor specific antibodies (DSA) Incidence of death, graft loss, delayed graft function (DGF), infection, and post-transplant malignancies.; Patient and allograft survival	6 months	No