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

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ClinicalTrials.gov Identifier: NCT00374803
Recruitment Status : Completed
First Posted : September 11, 2006
Results First Posted : May 8, 2012
Last Update Posted : April 28, 2016
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Rita Alloway, University of Cincinnati

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition End Stage Renal Disease (ESRD)
Intervention Drug: Mycophenolic Acid (Myfortic)
Enrollment 45
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.
Pre-assignment Details  
Arm/Group Title Myfortic 1080mg BID, 720mg BID Myfortic 720 mg Twice Daily
Hide Arm/Group Description Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter Myfortic 720 mg twice daily (1440 mg/day).
Period Title: Overall Study
Started 22 23
Completed 22 23
Not Completed 0 0
Arm/Group Title Myfortic 1080mg BID, 720mg BID Myfortic 720 mg Twice Daily Total
Hide Arm/Group Description Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter Myfortic 720 mg twice daily (1440 mg/day). Total of all reporting groups
Overall Number of Baseline Participants 22 23 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 23 participants 45 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
22
 100.0%
23
 100.0%
45
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 23 participants 45 participants
49  (14) 55  (13) 52  (14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 23 participants 45 participants
Female
11
  50.0%
10
  43.5%
21
  46.7%
Male
11
  50.0%
13
  56.5%
24
  53.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 23 participants 45 participants
22 23 45
1.Primary Outcome
Title Incidence of All Biopsy Proven Acute Rejection.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mycophenolic Acid Loading Group Mycophenolic Acid No Load Group
Hide Arm/Group Description:
Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 720 mg twice daily (1440 mg/day)
Overall Number of Participants Analyzed 22 23
Measure Type: Number
Unit of Measure: Participants
1 4
2.Secondary Outcome
Title Patient and Allograft Survival 12 Months
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mycophenolic Acid (Myfortic) Preload Mycophenolic Acid (Myfortic) Standard
Hide Arm/Group 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): • 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).

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

Mycophenolic 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).

Overall Number of Participants Analyzed 22 23
Measure Type: Number
Unit of Measure: participants
Patient Survival 22 23
Allograft Survival 22 22
3.Secondary Outcome
Title Renal Function at 12 Months
Hide Description Renal function measured by serum creatinine (SCr) at 12 months post-transplant
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mycophenolic Acid Loading Group Mycophenolic Acid No Load Group
Hide Arm/Group Description:
Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 720 mg twice daily (1440 mg/day)
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: mg/dL
1.36  (0.4) 1.5  (1.0)
4.Secondary Outcome
Title Incidence of Post Transplant Infections
Hide Description Incidence of post transplant infections that resulted in hospitalization
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mycophenolic Acid Loading Group Mycophenolic Acid No Load Group
Hide Arm/Group Description:
Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 720 mg twice daily (1440 mg/day)
Overall Number of Participants Analyzed 22 23
Measure Type: Number
Unit of Measure: participants
4 4
5.Secondary Outcome
Title GI Toxicities
Hide Description Hospitalizations due to Gastrointestinal (GI) toxicities of mycophenolic acid enteric coated (Myfortic)
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mycophenolic Acid Loading Group Mycophenolic Acid No Load Group
Hide Arm/Group Description:
Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 720 mg twice daily (1440 mg/day)
Overall Number of Participants Analyzed 22 23
Measure Type: Number
Unit of Measure: participants
5 4
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mycophenolic Acid Loading Group Mycophenolic Acid No Load Group
Hide Arm/Group Description Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 720 mg twice daily (1440 mg/day)
All-Cause Mortality
Mycophenolic Acid Loading Group Mycophenolic Acid No Load Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Mycophenolic Acid Loading Group Mycophenolic Acid No Load Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/22 (18.18%)      14/23 (60.87%)    
Cardiac disorders     
Myocardial Infarction * 1  0/22 (0.00%)  0 1/23 (4.35%)  1
Coronary Artery Bypass * 1  0/22 (0.00%)  0 1/23 (4.35%)  1
Gastrointestinal disorders     
Nausea/Vomiting * 1  2/22 (9.09%)  4 4/23 (17.39%)  4
Abdominal Pain * 1  0/22 (0.00%)  0 2/23 (8.70%)  2
Diarrhea * 1  0/22 (0.00%)  0 1/23 (4.35%)  1
Hemorrhoidal hemorrhage * 1  1/22 (4.55%)  1 1/23 (4.35%)  1
General disorders     
Fever * 1  1/22 (4.55%)  1 1/23 (4.35%)  1
Infections and infestations     
Urinary Tract Infection * 1  0/22 (0.00%)  0 2/23 (8.70%)  2
Wound Infection * 1  0/22 (0.00%)  0 1/23 (4.35%)  1
Investigations     
Creatinine Increased * 1  0/22 (0.00%)  0 4/23 (17.39%)  8
Metabolism and nutrition disorders     
Dehydration * 1  0/22 (0.00%)  0 1/23 (4.35%)  1
Musculoskeletal and connective tissue disorders     
Gout * 1  0/22 (0.00%)  0 1/23 (4.35%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Post-transplant lymphoproliferative disorder (PTLD) * 1  0/22 (0.00%)  0 1/23 (4.35%)  1
Nervous system disorders     
Altered Mental Status * 1  0/22 (0.00%)  0 1/23 (4.35%)  1
Renal and urinary disorders     
Acute Tubular Necrosis * 1  0/22 (0.00%)  0 1/23 (4.35%)  1
Acute Kidney Failure * 1  1/22 (4.55%)  1 0/23 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnea * 1  0/22 (0.00%)  0 1/23 (4.35%)  1
Chest Pain * 1  0/22 (0.00%)  0 1/23 (4.35%)  1
Surgical and medical procedures     
Dehiscence with evisceration * 1  0/22 (0.00%)  0 1/23 (4.35%)  2
Vascular disorders     
Worsening Hypertension * 1  1/22 (4.55%)  1 0/23 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Mycophenolic Acid Loading Group Mycophenolic Acid No Load Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/22 (77.27%)      15/23 (65.22%)    
Blood and lymphatic system disorders     
Leukopenia * 1  9/22 (40.91%)  10/22 (45.45%) 
Gastrointestinal disorders     
Diarrhea * 1  4/22 (18.18%)  4/23 (17.39%) 
Immune system disorders     
CMV Viremia * 1  2/22 (9.09%)  1/23 (4.35%) 
Skin and subcutaneous tissue disorders     
Wound dehiscence * 1  2/22 (9.09%)  0/23 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Rita Alloway, PharmD
Organization: University of Cincinnati
Phone: 5135581568
EMail: rita.alloway@uc.edu
Layout table for additonal information
Responsible Party: Rita Alloway, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00374803     History of Changes
Other Study ID Numbers: MyforticINVINT
First Submitted: September 8, 2006
First Posted: September 11, 2006
Results First Submitted: March 9, 2012
Results First Posted: May 8, 2012
Last Update Posted: April 28, 2016