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

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ClinicalTrials.gov Identifier: NCT01336296
Recruitment Status : Completed
First Posted : April 15, 2011
Results First Posted : April 11, 2016
Last Update Posted : August 2, 2016
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Adele Rike-Shields, University of Cincinnati

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Kidney Transplant Recipients
Intervention Drug: mycophenolic acid
Enrollment 61
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Myfortic Preload Myfortic Standard
Hide Arm/Group Description

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

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

Myfortic at time of transplant with Thymoglobulin induction

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

Period Title: Overall Study
Started 40 21
Completed 35 17
Not Completed 5 4
Arm/Group Title Myfortic Preload Myfortic Standard Total
Hide Arm/Group Description

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

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

Myfortic at time of transplant with Thymoglobulin induction

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

Total of all reporting groups
Overall Number of Baseline Participants 40 21 61
Hide Baseline Analysis Population Description
Intent to treat
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 21 participants 61 participants
55.1  (15) 55.8  (13.1) 55.4  (14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 21 participants 61 participants
Female
12
  30.0%
6
  28.6%
18
  29.5%
Male
28
  70.0%
15
  71.4%
43
  70.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 21 participants 61 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
  12.5%
2
   9.5%
7
  11.5%
White
35
  87.5%
19
  90.5%
54
  88.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants 21 participants 61 participants
40 21 61
1.Primary Outcome
Title Incidence of Biopsy-confirmed Acute Rejection by Banff '97 Criteria (Updated 2007) 3, 6 and 12 Months Post Transplant
Hide Description

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.

Time Frame 3, 6 and 12 months post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Myfortic Preload Myfortic Standard
Hide Arm/Group Description:

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

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

Myfortic at time of transplant with Thymoglobulin induction

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

Overall Number of Participants Analyzed 40 21
Measure Type: Number
Unit of Measure: participants
3 months 7 3
6 months 7 3
12 months 8 4
2.Secondary Outcome
Title Severity of Acute Rejection by Banff '97 Criteria
Hide Description

Severity of biopsy-confirmed acute rejection by Banff '97 Criteria (updated 2007) at 1 year. 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.

Time Frame Severity 1 year post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Myfortic Preload Myfortic Standard
Hide Arm/Group Description:

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

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

Myfortic at time of transplant with Thymoglobulin induction

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

Overall Number of Participants Analyzed 40 21
Measure Type: Number
Unit of Measure: participants
Grade IA 3 1
Grade IB 4 1
Grade IIA 1 0
Grade IIB 0 0
Antibody Mediated Rejection 0 1
Mixed Acute Rejection 0 1
3.Secondary Outcome
Title Difference in Renal Function
Hide Description Difference in renal function between groups at listed time points assessed by mean serum creatinine. Increased serum creatinine could indicate worsening renal function. A "normal" serum creatinine range for the transplant population varies by patient, but a typical range for Scr would be 1-2 mg/dL.
Time Frame Difference at 1 month, 3 months, 6 months, 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Myfortic Preload Myfortic Standard
Hide Arm/Group Description:

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

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

Myfortic at time of transplant with Thymoglobulin induction

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

Overall Number of Participants Analyzed 40 21
Mean (Standard Deviation)
Unit of Measure: mg/L
1 month 1.41  (0.4) 1.43  (0.6)
3 months 1.45  (0.5) 1.39  (0.5)
6 months 1.43  (0.4) 1.40  (0.6)
1 year 1.36  (0.4) 1.5  (1.0)
4.Secondary Outcome
Title Incidence of Chronic Alloantibody Rejection or Chronic Allograft Arteriopathy by Banff ‘97
Hide Description The Banff features suggestive of chronic rejection were: a) chronic transplant glomerulopathy: Glomerular basement membrane duplication and mesangial cell proliferation, and b) vasculopathy: Fibrous intimal thickening often with fragmentation of internal elastic lamina. Chronic changes in the interstitium (ci), tubules (ct), vessels (cv), and glomerulus (cg) were likewise graded into 0, 1, 2, and 3. The severity of interstitial fibrosis and tubular atrophy, as also chronic transplant glomerulopathy and vasculopathy were used to grade chronic allograft changes.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Myfortic Preload Myfortic Standard
Hide Arm/Group Description:

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

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

Myfortic at time of transplant with Thymoglobulin induction

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

Overall Number of Participants Analyzed 40 21
Measure Type: Number
Unit of Measure: participants
mild Chronic allograft nephropathy (CAN) 9 3
Moderate Chronic allograft nephropathy (CAN) 0 1
5.Secondary Outcome
Title Number of Patients Requiring Anti-lymphocyte Therapy for Acute Rejection
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Myfortic Preload Myfortic Standard
Hide Arm/Group Description:

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

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

Myfortic at time of transplant with Thymoglobulin induction

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

Overall Number of Participants Analyzed 40 21
Measure Type: Number
Unit of Measure: participants
Pulse methylprednisolone 5 3
Thymoglobulin 6 0
Plasmapheresis 0 2
Intravenous immunoglobulin (IVIg) 0 0
Rituximab 0 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Myfortic Preload Myfortic Standard
Hide Arm/Group Description

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

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

Myfortic at time of transplant with Thymoglobulin induction

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

All-Cause Mortality
Myfortic Preload Myfortic Standard
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Myfortic Preload Myfortic Standard
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/40 (47.50%)      10/21 (47.62%)    
Blood and lymphatic system disorders     
Anemia * 1  0/40 (0.00%)  0 1/21 (4.76%)  1
Hyperkalemia * 1  2/40 (5.00%)  2 0/21 (0.00%)  0
Neutropenia * 1  1/40 (2.50%)  1 0/21 (0.00%)  0
Bicarbonate Decrease * 1  1/40 (2.50%)  1 0/21 (0.00%)  0
Metabolic Acidosis * 1  1/40 (2.50%)  1 0/21 (0.00%)  0
High Blood Sugar * 1  1/40 (2.50%)  1 0/21 (0.00%)  0
Elevated Postassium * 1  0/40 (0.00%)  0 1/21 (4.76%)  1
BK Virus * 1  0/40 (0.00%)  0 1/21 (4.76%)  1
Disseminated Histoplasmosis * 1  0/40 (0.00%)  0 1/21 (4.76%)  1
Cardiac disorders     
Left Internal Carotid Artery Stenosis * 1  0/40 (0.00%)  0 1/21 (4.76%)  1
Chest Pain * 1  1/40 (2.50%)  1 0/21 (0.00%)  0
Gastrointestinal disorders     
Small Bowel Obstruction * 1  1/40 (2.50%)  1 0/21 (0.00%)  0
Nausea * 1  4/40 (10.00%)  4 2/21 (9.52%)  2
Abdominal Pain * 1  0/40 (0.00%)  0 1/21 (4.76%)  3
Diarrhea * 1  4/40 (10.00%)  4 2/21 (9.52%)  4
Vomiting * 1  4/40 (10.00%)  4 3/21 (14.29%)  3
General disorders     
Fever * 1  2/40 (5.00%)  2 2/21 (9.52%)  2
Gout Imflammation * 1  1/40 (2.50%)  1 0/21 (0.00%)  0
Rebabilitation of Debility * 1  1/40 (2.50%)  1 0/21 (0.00%)  0
Hepatobiliary disorders     
Elevated Liver Enzymes * 1  1/40 (2.50%)  1 0/21 (0.00%)  0
Infections and infestations     
Sepsis * 1  1/40 (2.50%)  1 0/21 (0.00%)  0
Wound Incision Infection * 1  1/40 (2.50%)  1 0/21 (0.00%)  0
E Coli Bactermia * 1  1/40 (2.50%)  1 0/21 (0.00%)  0
Appendicitis * 1  1/40 (2.50%)  1 0/21 (0.00%)  0
Injury, poisoning and procedural complications     
Wound Dehiscense * 1  0/40 (0.00%)  0 1/21 (4.76%)  1
Metabolism and nutrition disorders     
Dehydration * 1  0/40 (0.00%)  0 1/21 (4.76%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Urothelial Carcinoma * 1  0/40 (0.00%)  0 1/21 (4.76%)  1
Renal and urinary disorders     
Purcutaneous Nephrostomy * 1  0/40 (0.00%)  0 1/21 (4.76%)  1
Borderline Rejection * 1  3/40 (7.50%)  3 1/21 (4.76%)  1
Renal Dysfunction * 1  5/40 (12.50%)  6 3/21 (14.29%)  4
Fluid Aspiration * 1  1/40 (2.50%)  1 0/21 (0.00%)  0
Slow Creatine Decline * 1  1/40 (2.50%)  1 0/21 (0.00%)  0
Acute Allograft Dysfunction * 1  0/40 (0.00%)  0 1/21 (4.76%)  1
Serum Creatinine Increased * 1  6/40 (15.00%)  12 4/21 (19.05%)  7
Acute Mediated Rejection * 1  0/40 (0.00%)  0 1/21 (4.76%)  3
Hydronephrosis * 1  3/40 (7.50%)  3 0/21 (0.00%)  0
Ureteral Revision * 1  1/40 (2.50%)  1 0/21 (0.00%)  0
Banff 2A Rejection * 1  1/40 (2.50%)  1 0/21 (0.00%)  0
Obstructive Uropathy * 1  1/40 (2.50%)  1 0/21 (0.00%)  0
Perinephric Lymphocele * 1  1/40 (2.50%)  1 1/21 (4.76%)  1
Urinary Tract Infection * 1  0/40 (0.00%)  0 1/21 (4.76%)  1
Reproductive system and breast disorders     
Impotence * 1  1/40 (2.50%)  1 0/21 (0.00%)  0
Erectile Dysfunction * 1  1/40 (2.50%)  1 0/21 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Shortness of Breath * 1  1/40 (2.50%)  1 0/21 (0.00%)  0
Acute Hypoxemic Respiration Failure * 1  1/40 (2.50%)  1 0/21 (0.00%)  0
Pleural Effusion * 1  1/40 (2.50%)  1 0/21 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Myfortic Preload Myfortic Standard
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/40 (35.00%)      8/21 (38.10%)    
Blood and lymphatic system disorders     
Cytomegalovirus * 1  1/40 (2.50%)  1 0/21 (0.00%)  0
Gastrointestinal disorders     
Abdominal Pain * 1  0/40 (0.00%)  0 1/21 (4.76%)  3
Diarrhea * 1  4/40 (10.00%)  4 4/21 (19.05%) 
Vomiting * 1  4/40 (10.00%)  3/21 (14.29%)  3
Nausea * 1  6/40 (15.00%)  0/21 (0.00%)  0
General disorders     
Headache * 1  1/40 (2.50%)  1 0/21 (0.00%)  0
Dizziness * 1  1/40 (2.50%)  1 0/21 (0.00%)  0
Metabolism and nutrition disorders     
Weight Loss * 1  0/40 (0.00%)  0 1/21 (4.76%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (Unspecified)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Research Associate Professor
Organization: UCincinnati
Phone: 5135852145
EMail: adele.rike@uc.edu
Layout table for additonal information
Responsible Party: Adele Rike-Shields, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01336296     History of Changes
Other Study ID Numbers: Myfortic Preload
First Submitted: October 28, 2010
First Posted: April 15, 2011
Results First Submitted: April 30, 2015
Results First Posted: April 11, 2016
Last Update Posted: August 2, 2016