Trial Outcomes & Findings for Evaluate Effects and Safety of Pre-load Myfortic® in Transplant Patients (NCT NCT01336296)
NCT ID: NCT01336296
Last Updated: 2016-08-02
Results Overview
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.
COMPLETED
PHASE4
61 participants
3, 6 and 12 months post transplant
2016-08-02
Participant Flow
Participant milestones
| Measure |
Myfortic Preload
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 Standard
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 Study
STARTED
|
40
|
21
|
|
Overall Study
COMPLETED
|
35
|
17
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluate Effects and Safety of Pre-load Myfortic® in Transplant Patients
Baseline characteristics by cohort
| Measure |
Myfortic Preload
n=40 Participants
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 Standard
n=21 Participants
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
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.1 years
STANDARD_DEVIATION 15 • n=5 Participants
|
55.8 years
STANDARD_DEVIATION 13.1 • n=7 Participants
|
55.4 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
21 participants
n=7 Participants
|
61 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3, 6 and 12 months post transplantIncidence 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.
Outcome measures
| Measure |
Myfortic Preload
n=40 Participants
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 Standard
n=21 Participants
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
|
|---|---|---|
|
Incidence of Biopsy-confirmed Acute Rejection by Banff '97 Criteria (Updated 2007) 3, 6 and 12 Months Post Transplant
3 months
|
7 participants
|
3 participants
|
|
Incidence of Biopsy-confirmed Acute Rejection by Banff '97 Criteria (Updated 2007) 3, 6 and 12 Months Post Transplant
6 months
|
7 participants
|
3 participants
|
|
Incidence of Biopsy-confirmed Acute Rejection by Banff '97 Criteria (Updated 2007) 3, 6 and 12 Months Post Transplant
12 months
|
8 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Severity 1 year post transplantSeverity 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.
Outcome measures
| Measure |
Myfortic Preload
n=40 Participants
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 Standard
n=21 Participants
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
|
|---|---|---|
|
Severity of Acute Rejection by Banff '97 Criteria
Grade IA
|
3 participants
|
1 participants
|
|
Severity of Acute Rejection by Banff '97 Criteria
Grade IB
|
4 participants
|
1 participants
|
|
Severity of Acute Rejection by Banff '97 Criteria
Grade IIA
|
1 participants
|
0 participants
|
|
Severity of Acute Rejection by Banff '97 Criteria
Grade IIB
|
0 participants
|
0 participants
|
|
Severity of Acute Rejection by Banff '97 Criteria
Antibody Mediated Rejection
|
0 participants
|
1 participants
|
|
Severity of Acute Rejection by Banff '97 Criteria
Mixed Acute Rejection
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Difference at 1 month, 3 months, 6 months, 1 yearDifference 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.
Outcome measures
| Measure |
Myfortic Preload
n=40 Participants
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 Standard
n=21 Participants
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
|
|---|---|---|
|
Difference in Renal Function
6 months
|
1.43 mg/L
Standard Deviation 0.4
|
1.40 mg/L
Standard Deviation 0.6
|
|
Difference in Renal Function
1 year
|
1.36 mg/L
Standard Deviation 0.4
|
1.5 mg/L
Standard Deviation 1.0
|
|
Difference in Renal Function
1 month
|
1.41 mg/L
Standard Deviation 0.4
|
1.43 mg/L
Standard Deviation 0.6
|
|
Difference in Renal Function
3 months
|
1.45 mg/L
Standard Deviation 0.5
|
1.39 mg/L
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 1 yearThe 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.
Outcome measures
| Measure |
Myfortic Preload
n=40 Participants
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 Standard
n=21 Participants
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
|
|---|---|---|
|
Incidence of Chronic Alloantibody Rejection or Chronic Allograft Arteriopathy by Banff '97
mild Chronic allograft nephropathy (CAN)
|
9 participants
|
3 participants
|
|
Incidence of Chronic Alloantibody Rejection or Chronic Allograft Arteriopathy by Banff '97
Moderate Chronic allograft nephropathy (CAN)
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Myfortic Preload
n=40 Participants
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 Standard
n=21 Participants
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
|
|---|---|---|
|
Number of Patients Requiring Anti-lymphocyte Therapy for Acute Rejection
Pulse methylprednisolone
|
5 participants
|
3 participants
|
|
Number of Patients Requiring Anti-lymphocyte Therapy for Acute Rejection
Thymoglobulin
|
6 participants
|
0 participants
|
|
Number of Patients Requiring Anti-lymphocyte Therapy for Acute Rejection
Plasmapheresis
|
0 participants
|
2 participants
|
|
Number of Patients Requiring Anti-lymphocyte Therapy for Acute Rejection
Intravenous immunoglobulin (IVIg)
|
0 participants
|
0 participants
|
|
Number of Patients Requiring Anti-lymphocyte Therapy for Acute Rejection
Rituximab
|
0 participants
|
1 participants
|
Adverse Events
Myfortic Preload
Myfortic Standard
Serious adverse events
| Measure |
Myfortic Preload
n=40 participants at risk
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 Standard
n=21 participants at risk
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
|
|---|---|---|
|
Renal and urinary disorders
Purcutaneous Nephrostomy
|
0.00%
0/40
|
4.8%
1/21 • Number of events 1
|
|
Renal and urinary disorders
Borderline Rejection
|
7.5%
3/40 • Number of events 3
|
4.8%
1/21 • Number of events 1
|
|
Infections and infestations
Sepsis
|
2.5%
1/40 • Number of events 1
|
0.00%
0/21
|
|
Renal and urinary disorders
Renal Dysfunction
|
12.5%
5/40 • Number of events 6
|
14.3%
3/21 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
2.5%
1/40 • Number of events 1
|
0.00%
0/21
|
|
Gastrointestinal disorders
Small Bowel Obstruction
|
2.5%
1/40 • Number of events 1
|
0.00%
0/21
|
|
Renal and urinary disorders
Fluid Aspiration
|
2.5%
1/40 • Number of events 1
|
0.00%
0/21
|
|
Respiratory, thoracic and mediastinal disorders
Acute Hypoxemic Respiration Failure
|
2.5%
1/40 • Number of events 1
|
0.00%
0/21
|
|
Renal and urinary disorders
Slow Creatine Decline
|
2.5%
1/40 • Number of events 1
|
0.00%
0/21
|
|
Infections and infestations
Wound Incision Infection
|
2.5%
1/40 • Number of events 1
|
0.00%
0/21
|
|
Gastrointestinal disorders
Nausea
|
10.0%
4/40 • Number of events 4
|
9.5%
2/21 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/40
|
4.8%
1/21 • Number of events 3
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/40
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
4/40 • Number of events 4
|
9.5%
2/21 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
4/40 • Number of events 4
|
14.3%
3/21 • Number of events 3
|
|
Renal and urinary disorders
Acute Allograft Dysfunction
|
0.00%
0/40
|
4.8%
1/21 • Number of events 1
|
|
General disorders
Fever
|
5.0%
2/40 • Number of events 2
|
9.5%
2/21 • Number of events 2
|
|
Cardiac disorders
Left Internal Carotid Artery Stenosis
|
0.00%
0/40
|
4.8%
1/21 • Number of events 1
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
5.0%
2/40 • Number of events 2
|
0.00%
0/21
|
|
General disorders
Gout Imflammation
|
2.5%
1/40 • Number of events 1
|
0.00%
0/21
|
|
Renal and urinary disorders
Serum Creatinine Increased
|
15.0%
6/40 • Number of events 12
|
19.0%
4/21 • Number of events 7
|
|
Infections and infestations
E Coli Bactermia
|
2.5%
1/40 • Number of events 1
|
0.00%
0/21
|
|
General disorders
Rebabilitation of Debility
|
2.5%
1/40 • Number of events 1
|
0.00%
0/21
|
|
Cardiac disorders
Chest Pain
|
2.5%
1/40 • Number of events 1
|
0.00%
0/21
|
|
Renal and urinary disorders
Acute Mediated Rejection
|
0.00%
0/40
|
4.8%
1/21 • Number of events 3
|
|
Reproductive system and breast disorders
Impotence
|
2.5%
1/40 • Number of events 1
|
0.00%
0/21
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
2.5%
1/40 • Number of events 1
|
0.00%
0/21
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.5%
1/40 • Number of events 1
|
0.00%
0/21
|
|
Blood and lymphatic system disorders
Bicarbonate Decrease
|
2.5%
1/40 • Number of events 1
|
0.00%
0/21
|
|
Blood and lymphatic system disorders
Metabolic Acidosis
|
2.5%
1/40 • Number of events 1
|
0.00%
0/21
|
|
Blood and lymphatic system disorders
High Blood Sugar
|
2.5%
1/40 • Number of events 1
|
0.00%
0/21
|
|
Renal and urinary disorders
Hydronephrosis
|
7.5%
3/40 • Number of events 3
|
0.00%
0/21
|
|
Renal and urinary disorders
Ureteral Revision
|
2.5%
1/40 • Number of events 1
|
0.00%
0/21
|
|
Renal and urinary disorders
Banff 2A Rejection
|
2.5%
1/40 • Number of events 1
|
0.00%
0/21
|
|
Infections and infestations
Appendicitis
|
2.5%
1/40 • Number of events 1
|
0.00%
0/21
|
|
Hepatobiliary disorders
Elevated Liver Enzymes
|
2.5%
1/40 • Number of events 1
|
0.00%
0/21
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
2.5%
1/40 • Number of events 1
|
0.00%
0/21
|
|
Blood and lymphatic system disorders
Elevated Postassium
|
0.00%
0/40
|
4.8%
1/21 • Number of events 1
|
|
Renal and urinary disorders
Obstructive Uropathy
|
2.5%
1/40 • Number of events 1
|
0.00%
0/21
|
|
Injury, poisoning and procedural complications
Wound Dehiscense
|
0.00%
0/40
|
4.8%
1/21 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/40
|
4.8%
1/21 • Number of events 1
|
|
Blood and lymphatic system disorders
BK Virus
|
0.00%
0/40
|
4.8%
1/21 • Number of events 1
|
|
Renal and urinary disorders
Perinephric Lymphocele
|
2.5%
1/40 • Number of events 1
|
4.8%
1/21 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urothelial Carcinoma
|
0.00%
0/40
|
4.8%
1/21 • Number of events 1
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/40
|
4.8%
1/21 • Number of events 1
|
|
Blood and lymphatic system disorders
Disseminated Histoplasmosis
|
0.00%
0/40
|
4.8%
1/21 • Number of events 1
|
Other adverse events
| Measure |
Myfortic Preload
n=40 participants at risk
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 Standard
n=21 participants at risk
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
|
|---|---|---|
|
General disorders
Headache
|
2.5%
1/40 • Number of events 1
|
0.00%
0/21
|
|
General disorders
Dizziness
|
2.5%
1/40 • Number of events 1
|
0.00%
0/21
|
|
Metabolism and nutrition disorders
Weight Loss
|
0.00%
0/40
|
4.8%
1/21 • Number of events 1
|
|
Blood and lymphatic system disorders
Cytomegalovirus
|
2.5%
1/40 • Number of events 1
|
0.00%
0/21
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/40
|
4.8%
1/21 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
4/40 • Number of events 4
|
19.0%
4/21
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
4/40
|
14.3%
3/21 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
15.0%
6/40
|
0.00%
0/21
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place