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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00374803

Enrollment

Registered

2006-09-11

Start date

2006-04-30

Completion date

2008-01-31

Last updated

2016-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease (ESRD)

Keywords

Kidney, Transplant, Corticosteroid, Myfortic

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.

Interventions

DRUGMycophenolic Acid (Myfortic)

* 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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of All Biopsy Proven Acute Rejection.	12 months	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

Measure	Time frame	Description
Patient and Allograft Survival 12 Months	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	12 months	Renal function measured by serum creatinine (SCr) at 12 months post-transplant
Incidence of Post Transplant Infections	12 months	Incidence of post transplant infections that resulted in hospitalization
GI Toxicities	12 months	Hospitalizations due to Gastrointestinal (GI) toxicities of mycophenolic acid enteric coated (Myfortic)

Countries

United States

Participant flow

Recruitment details

Single center, 45 patients consecutively enrolled. Patients were randomized into two groups: (group 1) will be receive 2160 mg/day for two weeks, followed by 1440 mg/day thereafter, and (group 2) will receive 1440 mg/day for the duration of the study.

Participants by arm

Arm	Count
Myfortic 1080mg BID, 720mg BID Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter	22
Myfortic 720 mg Twice Daily Myfortic 720 mg twice daily (1440 mg/day).	23
Total	45

Baseline characteristics

Characteristic	Myfortic 720 mg Twice Daily	Myfortic 1080mg BID, 720mg BID	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	23 Participants	22 Participants	45 Participants
Age, Continuous	55 years STANDARD_DEVIATION 13	49 years STANDARD_DEVIATION 14	52 years STANDARD_DEVIATION 14
Region of Enrollment United States	23 participants	22 participants	45 participants
Sex: Female, Male Female	10 Participants	11 Participants	21 Participants
Sex: Female, Male Male	13 Participants	11 Participants	24 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	17 / 22	15 / 23
serious Total, serious adverse events	4 / 22	14 / 23

Arm	Measure	Value (MEAN)	Dispersion
Mycophenolic Acid Loading Group	Renal Function at 12 Months	1.36 mg/dL	Standard Deviation 0.4
Mycophenolic Acid No Load Group	Renal Function at 12 Months	1.5 mg/dL	Standard Deviation 1

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026