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

NCT01336296 | Completed Phase 4 Results

• 1 other identifier: Myfortic Preload
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplant Recipients

Outcome Measures

Primary Outcomes (1)

• Incidence of Biopsy-confirmed Acute Rejection by Banff '97 Criteria (Updated 2007) 3, 6 and 12 Months Post Transplant

  Incidence of biopsy-confirmed acute rejection by Banff '97 Criteria (updated 2007) post transplant. The acute form of T-cell mediated rejection is furthermore subclassified as follows. Since this is the most common form of rejection, it is useful to know: As with humoral rejection, there are both acute \& chronic forms: The acute form of T-cell mediated rejection is furthermore subclassified as follows. Since this is the most common form of rejection, it is useful to know: Class IA: there is at least 25% of parenchymal showing interstitial infiltration and foci of moderate tubulitis (defined as a certain number of immune cells present in tubular cross-sections). Class IB: just like Class IA except there is more severe tubulitis. Class IIA: there is mild-to-moderate intimal arteritis. Class IIB: there is severe intimal arteritis comprising at least 25% of the lumenal area. Class III: there is transmural (e.g. the full vessel wall thickness) arteritis.

  3, 6 and 12 months post transplant

Secondary Outcomes (4)

• Severity of Acute Rejection by Banff '97 Criteria

  Severity 1 year post transplant

• Difference in Renal Function

  Difference at 1 month, 3 months, 6 months, 1 year

• Incidence of Chronic Alloantibody Rejection or Chronic Allograft Arteriopathy by Banff '97

  1 year

• Number of Patients Requiring Anti-lymphocyte Therapy for Acute Rejection

  1 year

Study Arms (2)

Myfortic preload

ACTIVE COMPARATOR

Initiation of mycophenolic acid (Myfortic) 2 weeks prior to transplantation (with Simulect induction at time of transplant)

Drug: mycophenolic acid

Myfortic standard

ACTIVE COMPARATOR

mycophenolic acid (Myfortic) at time of transplant with Thymoglobulin induction

Drug: mycophenolic acid

Interventions

mycophenolic acid DRUG

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

Also known as: Myfortic

Myfortic preload; Myfortic standard

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Cincinnati: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267, United States

Location

MeSH Terms

Interventions

Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Results Point of Contact

• Title: Research Associate Professor
• Organization: UCincinnati

adele.rike@uc.edu

5135852145

Study Officials

• Adele Shields, Pharm.D.

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PharmD

Study Record Dates

• First Submitted: October 28, 2010
• First Posted: April 15, 2011
• Study Start: September 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: August 2, 2016
• Results First Posted: April 11, 2016

Record last verified: 2016-07

Locations

US (1)