Study of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal

NCT00374803 | Completed Phase 4 Results

• 1 other identifier: MyforticINVINT
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief Summary

To determine the safety and efficacy of a new formulation of Myfortic in combination with tacrolimus and thymoglobulin.

Conditions

End Stage Renal Disease (ESRD)

Keywords

Kidney; Transplant; Corticosteroid; Myfortic

Outcome Measures

Primary Outcomes (1)

• Incidence of All Biopsy Proven Acute Rejection.

  Treatment efficacy, defined as the incidence of all biopsy proven acute rejection. Biopsy was proven with tissue samples collected on patients with elevated serum creatinine

  12 months

Secondary Outcomes (4)

• Patient and Allograft Survival 12 Months

  12 months

• Renal Function at 12 Months

  12 months

• Incidence of Post Transplant Infections

  12 months

• GI Toxicities

  12 months

Study Arms (2)

Mycophenolic Acid (Myfortic) Preload

EXPERIMENTAL

Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter

Drug: Mycophenolic Acid (Myfortic)

Mycophenolic Acid (Myfortic) Standard

ACTIVE COMPARATOR

Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day).

Drug: Mycophenolic Acid (Myfortic)

Interventions

Mycophenolic Acid (Myfortic) DRUG

* Group 1: Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter * Group 2: Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day).

Also known as: mycophenolic acid enteric coated

Mycophenolic Acid (Myfortic) Preload; Mycophenolic Acid (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:

• Males and females between 18 and 75 years of age.
• Patients who are primary or repeat cadaveric, living unrelated or non-HLA identical living related donor renal transplant recipients.

You may not qualify if:

• Patient previously received or is receiving an organ transplant other than kidney.
• Primary or re-transplant from human leukocyte antigen (HLA)-identical living donor.
• Recipient or donor is known to be seropositive for hepatitis C virus (HCV), hepatitis B virus (HBV), or human immunodeficiency virus (HIV).
• Uncontrolled concomitant infection or other unstable medical condition.
• Patients that received an investigational drug in the 30 days prior to transplant.
• Known hypersensitivity to tacrolimus, mycophenolate mofetil (MMF), enteric-coated mycophenolic acid, rabbit anti-thymocyte globulin, or corticosteroids.
• Receiving chronic steroid therapy at the time of transplant.
• History of malignancy in last 5 years.
• Pregnant or lactating.

Sponsors & Collaborators

• University of Cincinnati: lead
• Novartis: collaborator

Study Sites (2)

The Christ Hospital

Cincinnati, Ohio, 45267, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Mycophenolic Acid

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Rita Alloway, PharmD
• Organization: University of Cincinnati

rita.alloway@uc.edu

5135581568

Study Officials

• Rita Alloway, PharmD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• 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, FCCP

Study Record Dates

• First Submitted: September 8, 2006
• First Posted: September 11, 2006
• Study Start: April 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: April 28, 2016
• Results First Posted: May 8, 2012

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)