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

Primary Purpose

End Stage Renal Disease (ESRD)

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Mycophenolic Acid (Myfortic)
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease (ESRD) focused on measuring Kidney, Transplant, Corticosteroid, Myfortic

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • The Christ Hospital
  • University of Cincinnati

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mycophenolic Acid (Myfortic) Preload

Mycophenolic Acid (Myfortic) Standard

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patient and Allograft Survival 12 Months
Patient and allograft survival at 12 months post-transplant. Allograft survival is different from rejection. An allograft can have rejection, but the allograft can still have survival. If an allograft fails and is no longer functioning this would be considered allograft failure and non-survival.
Renal Function at 12 Months
Renal function measured by serum creatinine (SCr) at 12 months post-transplant
Incidence of Post Transplant Infections
Incidence of post transplant infections that resulted in hospitalization
GI Toxicities
Hospitalizations due to Gastrointestinal (GI) toxicities of mycophenolic acid enteric coated (Myfortic)

Full Information

First Posted
September 8, 2006
Last Updated
March 28, 2016
Sponsor
University of Cincinnati
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00374803
Brief Title
Study of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal
Official Title
A 12-month, Prospective, Randomized, Single Center, Open Label Pilot Study to Evaluate the Safety and Efficacy of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To determine the safety and efficacy of a new formulation of Myfortic in combination with tacrolimus and thymoglobulin.
Detailed Description
Evaluate the safety and efficacy of Myfortic in combination with tacrolimus and anti-thymocyte globulin in an early corticosteroid withdrawal protocol. Secondary objective is to determine the pharmacokinetic-pharmacodynamic profile of Myfortic in a corticosteroid withdrawal protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease (ESRD)
Keywords
Kidney, Transplant, Corticosteroid, Myfortic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mycophenolic Acid (Myfortic) Preload
Arm Type
Experimental
Arm Description
Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
Arm Title
Mycophenolic Acid (Myfortic) Standard
Arm Type
Active Comparator
Arm Description
Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day).
Intervention Type
Drug
Intervention Name(s)
Mycophenolic Acid (Myfortic)
Other Intervention Name(s)
mycophenolic acid enteric coated
Intervention Description
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).
Primary Outcome Measure Information:
Title
Incidence of All Biopsy Proven Acute Rejection.
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Patient and Allograft Survival 12 Months
Description
Patient and allograft survival at 12 months post-transplant. Allograft survival is different from rejection. An allograft can have rejection, but the allograft can still have survival. If an allograft fails and is no longer functioning this would be considered allograft failure and non-survival.
Time Frame
12 months
Title
Renal Function at 12 Months
Description
Renal function measured by serum creatinine (SCr) at 12 months post-transplant
Time Frame
12 months
Title
Incidence of Post Transplant Infections
Description
Incidence of post transplant infections that resulted in hospitalization
Time Frame
12 months
Title
GI Toxicities
Description
Hospitalizations due to Gastrointestinal (GI) toxicities of mycophenolic acid enteric coated (Myfortic)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rita Alloway, PharmD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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