Trial Outcomes & Findings for Evaluation of the Therapeutic Benefit of an Initial Intensified Dosing Regimen of Mycophenolate Sodium Versus a Standard Regimen in Renal Transplant Patients (NCT NCT00419926)
NCT ID: NCT00419926
Last Updated: 2011-03-01
Results Overview
To evaluate therapeutic benefit by comparing the efficacy defined as the number of participants with treatment failure (biopsy-proven acute rejection \[BPAR\], graft loss \[GFL\] or death) at 6 months post-transplant. BPAR was defined as a biopsy graded IA, IB, IIA, IIB or III using Banff 2000 classification. A graft core biopsy was performed within 24 hours of initiation of anti-rejection therapy. GFL was defined as the day the allograft was presumed lost (the day the patient started dialysis, the day of nephrectomy or the day of irreversible graft loss demonstrated by imaging techniques.)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
313 participants
Primary outcome timeframe
6 months
Results posted on
2011-03-01
Participant Flow
Participant milestones
| Measure |
Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen
In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
|
Standard Mycophenolate Sodium (Myfortic) Dosing Regimen
In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
|
|---|---|---|
|
Overall Study
STARTED
|
155
|
158
|
|
Overall Study
COMPLETED
|
141
|
148
|
|
Overall Study
NOT COMPLETED
|
14
|
10
|
Reasons for withdrawal
| Measure |
Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen
In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
|
Standard Mycophenolate Sodium (Myfortic) Dosing Regimen
In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
3
|
|
Overall Study
Administrative Problem
|
4
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Death
|
2
|
1
|
Baseline Characteristics
Evaluation of the Therapeutic Benefit of an Initial Intensified Dosing Regimen of Mycophenolate Sodium Versus a Standard Regimen in Renal Transplant Patients
Baseline characteristics by cohort
| Measure |
Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen
n=155 Participants
In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
|
Standard Mycophenolate Sodium (Myfortic) Dosing Regimen
n=158 Participants
In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
|
Total
n=313 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 50 years
|
100 participants
n=5 Participants
|
102 participants
n=7 Participants
|
202 participants
n=5 Participants
|
|
Age, Customized
>=50 years
|
55 participants
n=5 Participants
|
56 participants
n=7 Participants
|
111 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
102 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
206 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Intention to treat (ITT) population.
To evaluate therapeutic benefit by comparing the efficacy defined as the number of participants with treatment failure (biopsy-proven acute rejection \[BPAR\], graft loss \[GFL\] or death) at 6 months post-transplant. BPAR was defined as a biopsy graded IA, IB, IIA, IIB or III using Banff 2000 classification. A graft core biopsy was performed within 24 hours of initiation of anti-rejection therapy. GFL was defined as the day the allograft was presumed lost (the day the patient started dialysis, the day of nephrectomy or the day of irreversible graft loss demonstrated by imaging techniques.)
Outcome measures
| Measure |
Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen
n=155 Participants
In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
|
Standard Mycophenolate Sodium (Myfortic) Dosing Regimen
n=158 Participants
In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
|
|---|---|---|
|
Number of Patients With Treatment Failure 6-months Post Transplant Measured by the Combined Incidence of Biopsy Proven Acute Rejection, Graft Loss, and Death
|
33 number of participants
|
36 number of participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Per Protocol (PP) population.
To evaluate therapeutic benefit by comparing the efficacy defined as the number of participants with treatment failure (biopsy-proven acute rejection \[BPAR\], graft loss \[GFL\] or death) at 6 months post-transplant. BPAR was defined as a biopsy graded IA, IB, IIA, IIB or III using Banff 2000 classification. A graft core biopsy was performed within 24 hours of initiation of anti-rejection therapy. GFL was defined as the day the allograft was presumed lost (the day the patient started dialysis, the day of nephrectomy or the day of irreversible graft loss demonstrated by imaging techniques.)
Outcome measures
| Measure |
Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen
n=129 Participants
In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
|
Standard Mycophenolate Sodium (Myfortic) Dosing Regimen
n=139 Participants
In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
|
|---|---|---|
|
Number of Patients With Treatment Failure 6-months Post Transplant Measured by the Combined Incidence of Biopsy Proven Acute Rejection, Graft Loss, and Death
|
26 number of participants
|
35 number of participants
|
SECONDARY outcome
Timeframe: 21 and 84 daysPopulation: Intention to treat (ITT) population.
The overall treatment differences of the number of participants with at least one occurrence of the composite event BPAR, GFL or death at study days 21 and 84 post-transplantation. BPAR was defined as a biopsy graded IA, IB, IIA, IIB or III using Banff 2000 classification. A graft core biopsy was performed within 24 hours of initiation of anti-rejection therapy. GFL was defined as the day the allograft was presumed lost (the day the patient started dialysis, the day of nephrectomy or the day of irreversible graft loss demonstrated by imaging techniques.)
Outcome measures
| Measure |
Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen
n=155 Participants
In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
|
Standard Mycophenolate Sodium (Myfortic) Dosing Regimen
n=158 Participants
In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
|
|---|---|---|
|
Comparison of Overall Treatment Failure at Days 21 and 84 Post-transplantation Assessed by Biopsy Proven Acute Rejection (BPAR), GFL, and Death
Day 21
|
20 number of participants
|
21 number of participants
|
|
Comparison of Overall Treatment Failure at Days 21 and 84 Post-transplantation Assessed by Biopsy Proven Acute Rejection (BPAR), GFL, and Death
Day 84
|
33 number of participants
|
34 number of participants
|
SECONDARY outcome
Timeframe: 21 and 84 daysPopulation: Per Protocol (PP) population.
The overall treatment differences of the number of participants with at least one occurrence of the composite event BPAR, GFL or death at study days 21 and 84 post-transplantation. BPAR was defined as a biopsy graded IA, IB, IIA, IIB or III using Banff 2000 classification. A graft core biopsy was performed within 24 hours of initiation of anti-rejection therapy. GFL was defined as the day the allograft was presumed lost (the day the patient started dialysis, the day of nephrectomy or the day of irreversible graft loss demonstrated by imaging techniques.)
Outcome measures
| Measure |
Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen
n=129 Participants
In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
|
Standard Mycophenolate Sodium (Myfortic) Dosing Regimen
n=139 Participants
In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
|
|---|---|---|
|
Comparison of Overall Treatment Failure at Days 21 and 84 Post-transplantation Assessed by Biopsy Proven Acute Rejection (BPAR), GFL, and Death
Day 21
|
14 number of participants
|
20 number of participants
|
|
Comparison of Overall Treatment Failure at Days 21 and 84 Post-transplantation Assessed by Biopsy Proven Acute Rejection (BPAR), GFL, and Death
Day 84
|
26 number of participants
|
33 number of participants
|
SECONDARY outcome
Timeframe: at 21 days, 84 days and 180 daysPopulation: Intention to treat (ITT) population.
The Modification of Diet in Renal Disease (MDRD) formula was used to calculate the GFR. Serum creatinine levels, age, sex and race were used to estimate the GFR levels in mL/min/1.73m\^2.
Outcome measures
| Measure |
Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen
n=155 Participants
In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
|
Standard Mycophenolate Sodium (Myfortic) Dosing Regimen
n=158 Participants
In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
|
|---|---|---|
|
Renal Function Assessed by Glomerular Filtration Rate (GFR)at Each Visit
At 21 days
|
47.3 (mL/min/1.73m^2)
Standard Deviation 20.05
|
46.8 (mL/min/1.73m^2)
Standard Deviation 21.00
|
|
Renal Function Assessed by Glomerular Filtration Rate (GFR)at Each Visit
At 84 days
|
52.1 (mL/min/1.73m^2)
Standard Deviation 19.80
|
51.8 (mL/min/1.73m^2)
Standard Deviation 20.21
|
|
Renal Function Assessed by Glomerular Filtration Rate (GFR)at Each Visit
At 180 days
|
53.5 (mL/min/1.73m^2)
Standard Deviation 21.05
|
51.3 (mL/min/1.73m^2)
Standard Deviation 25.14
|
SECONDARY outcome
Timeframe: at 21 days, 84 days and 180 daysOutcome measures
Outcome data not reported
Adverse Events
Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen
Serious events: 74 serious events
Other events: 143 other events
Deaths: 0 deaths
Standard Mycophenolate Sodium (Myfortic) Dosing Regimen
Serious events: 68 serious events
Other events: 145 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen
n=150 participants at risk
In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
|
Standard Mycophenolate Sodium (Myfortic) Dosing Regimen
n=154 participants at risk
In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
2.7%
4/150
|
0.00%
0/154
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.67%
1/150
|
0.00%
0/154
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.67%
1/150
|
0.00%
0/154
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.67%
1/150
|
0.00%
0/154
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.67%
1/150
|
0.00%
0/154
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/150
|
0.65%
1/154
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/150
|
0.65%
1/154
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
3/150
|
0.00%
0/154
|
|
Cardiac disorders
Cardiac arrest
|
0.67%
1/150
|
0.00%
0/154
|
|
Cardiac disorders
Cardiac hypertrophy
|
0.67%
1/150
|
0.00%
0/154
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/150
|
0.65%
1/154
|
|
Cardiac disorders
Myocardial ischaemia
|
0.67%
1/150
|
0.00%
0/154
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.67%
1/150
|
0.00%
0/154
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
3/150
|
0.65%
1/154
|
|
Gastrointestinal disorders
Colonic pseudo-obstruction
|
0.67%
1/150
|
0.00%
0/154
|
|
Gastrointestinal disorders
Diarrhoea
|
0.67%
1/150
|
1.9%
3/154
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.67%
1/150
|
0.00%
0/154
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.67%
1/150
|
0.00%
0/154
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/150
|
0.65%
1/154
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.67%
1/150
|
0.65%
1/154
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/150
|
0.65%
1/154
|
|
Gastrointestinal disorders
Nausea
|
0.67%
1/150
|
0.65%
1/154
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.67%
1/150
|
0.00%
0/154
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/150
|
0.65%
1/154
|
|
Gastrointestinal disorders
Peritonitis
|
0.67%
1/150
|
0.00%
0/154
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/150
|
0.65%
1/154
|
|
Gastrointestinal disorders
Vomiting
|
0.67%
1/150
|
0.65%
1/154
|
|
General disorders
Chest discomfort
|
0.67%
1/150
|
0.00%
0/154
|
|
General disorders
Pyrexia
|
0.67%
1/150
|
0.65%
1/154
|
|
Immune system disorders
Kidney transplant rejection
|
0.67%
1/150
|
4.5%
7/154
|
|
Immune system disorders
Transplant rejection
|
0.00%
0/150
|
0.65%
1/154
|
|
Infections and infestations
BK virus infection
|
0.00%
0/150
|
0.65%
1/154
|
|
Infections and infestations
Cystitis escherichia
|
0.67%
1/150
|
0.00%
0/154
|
|
Infections and infestations
Cytomegalovirus infection
|
6.7%
10/150
|
10.4%
16/154
|
|
Infections and infestations
Cytomegalovirus syndrome
|
0.00%
0/150
|
0.65%
1/154
|
|
Infections and infestations
Gastroenteritis
|
1.3%
2/150
|
0.65%
1/154
|
|
Infections and infestations
Haematoma infection
|
0.00%
0/150
|
0.65%
1/154
|
|
Infections and infestations
Herpes zoster
|
0.67%
1/150
|
1.3%
2/154
|
|
Infections and infestations
Human polyomavirus infection
|
0.67%
1/150
|
0.00%
0/154
|
|
Infections and infestations
Incision site abscess
|
0.67%
1/150
|
0.00%
0/154
|
|
Infections and infestations
Incision site infection
|
0.00%
0/150
|
1.3%
2/154
|
|
Infections and infestations
Infected lymphocele
|
0.00%
0/150
|
0.65%
1/154
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/150
|
0.65%
1/154
|
|
Infections and infestations
Parotitis
|
0.00%
0/150
|
0.65%
1/154
|
|
Infections and infestations
Pneumonia
|
0.00%
0/150
|
1.3%
2/154
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/150
|
0.65%
1/154
|
|
Infections and infestations
Pyelonephritis
|
0.67%
1/150
|
0.00%
0/154
|
|
Infections and infestations
Renal cyst infection
|
0.67%
1/150
|
0.00%
0/154
|
|
Infections and infestations
Sepsis
|
0.67%
1/150
|
0.00%
0/154
|
|
Infections and infestations
Septic shock
|
0.67%
1/150
|
0.00%
0/154
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.67%
1/150
|
0.00%
0/154
|
|
Infections and infestations
Tuberculosis
|
0.67%
1/150
|
0.00%
0/154
|
|
Infections and infestations
Upper respiratory tract infection
|
0.67%
1/150
|
0.65%
1/154
|
|
Infections and infestations
Urinary tract infection
|
6.0%
9/150
|
7.1%
11/154
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.67%
1/150
|
0.00%
0/154
|
|
Infections and infestations
Urosepsis
|
0.00%
0/150
|
0.65%
1/154
|
|
Infections and infestations
Viral infection
|
0.67%
1/150
|
0.00%
0/154
|
|
Infections and infestations
Wound infection
|
0.67%
1/150
|
0.00%
0/154
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/150
|
0.65%
1/154
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
4.0%
6/150
|
0.65%
1/154
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.67%
1/150
|
0.00%
0/154
|
|
Injury, poisoning and procedural complications
Foreign body trauma
|
0.00%
0/150
|
0.65%
1/154
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/150
|
0.65%
1/154
|
|
Injury, poisoning and procedural complications
Perirenal haematoma
|
1.3%
2/150
|
0.65%
1/154
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/150
|
0.65%
1/154
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.00%
0/150
|
0.65%
1/154
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/150
|
0.65%
1/154
|
|
Injury, poisoning and procedural complications
Post procedural urine leak
|
0.00%
0/150
|
1.3%
2/154
|
|
Injury, poisoning and procedural complications
Renal graft loss
|
1.3%
2/150
|
2.6%
4/154
|
|
Injury, poisoning and procedural complications
Seroma
|
0.67%
1/150
|
0.00%
0/154
|
|
Injury, poisoning and procedural complications
Shunt thrombosis
|
0.00%
0/150
|
0.65%
1/154
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
1.3%
2/150
|
0.00%
0/154
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.67%
1/150
|
0.00%
0/154
|
|
Injury, poisoning and procedural complications
Wound decomposition
|
0.67%
1/150
|
0.00%
0/154
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.67%
1/150
|
0.65%
1/154
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.67%
1/150
|
0.00%
0/154
|
|
Investigations
Blood creatinine increased
|
3.3%
5/150
|
3.2%
5/154
|
|
Investigations
Blood glucose increased
|
0.00%
0/150
|
0.65%
1/154
|
|
Investigations
Cytomegalovirus test
|
0.67%
1/150
|
0.00%
0/154
|
|
Investigations
Cytomegalovirus test positive
|
0.67%
1/150
|
0.00%
0/154
|
|
Investigations
Urine output decreased
|
0.67%
1/150
|
0.00%
0/154
|
|
Metabolism and nutrition disorders
Dehydration
|
1.3%
2/150
|
0.65%
1/154
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.67%
1/150
|
0.65%
1/154
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.67%
1/150
|
0.00%
0/154
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.67%
1/150
|
0.00%
0/154
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.67%
1/150
|
0.00%
0/154
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/150
|
0.65%
1/154
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/150
|
0.65%
1/154
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/150
|
0.65%
1/154
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.67%
1/150
|
0.00%
0/154
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.67%
1/150
|
0.00%
0/154
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
0.67%
1/150
|
0.00%
0/154
|
|
Nervous system disorders
Cerebrovascular accident
|
0.67%
1/150
|
0.00%
0/154
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.67%
1/150
|
0.00%
0/154
|
|
Nervous system disorders
Hemiparesis
|
0.67%
1/150
|
0.00%
0/154
|
|
Nervous system disorders
Migraine
|
0.67%
1/150
|
0.00%
0/154
|
|
Nervous system disorders
Reversible posterior leukoencephalopathy syndrome
|
0.67%
1/150
|
0.00%
0/154
|
|
Nervous system disorders
Stupor
|
0.00%
0/150
|
0.65%
1/154
|
|
Nervous system disorders
Syncope
|
0.67%
1/150
|
0.00%
0/154
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/150
|
0.65%
1/154
|
|
Renal and urinary disorders
Extravasation of urine
|
0.67%
1/150
|
0.00%
0/154
|
|
Renal and urinary disorders
Haematuria
|
0.67%
1/150
|
0.00%
0/154
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.67%
1/150
|
0.00%
0/154
|
|
Renal and urinary disorders
Hydronephrosis
|
1.3%
2/150
|
1.3%
2/154
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.67%
1/150
|
0.00%
0/154
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.67%
1/150
|
0.65%
1/154
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/150
|
0.65%
1/154
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/150
|
0.65%
1/154
|
|
Renal and urinary disorders
Renal impairment
|
1.3%
2/150
|
0.65%
1/154
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.67%
1/150
|
0.00%
0/154
|
|
Renal and urinary disorders
Renal vein thrombosis
|
0.67%
1/150
|
0.65%
1/154
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.67%
1/150
|
0.65%
1/154
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/150
|
0.65%
1/154
|
|
Renal and urinary disorders
Urinary fistula
|
0.00%
0/150
|
1.3%
2/154
|
|
Renal and urinary disorders
Urinary retention
|
0.67%
1/150
|
0.00%
0/154
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.67%
1/150
|
0.00%
0/154
|
|
Renal and urinary disorders
Urinoma
|
0.00%
0/150
|
0.65%
1/154
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.67%
1/150
|
0.00%
0/154
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.67%
1/150
|
0.00%
0/154
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.67%
1/150
|
0.65%
1/154
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/150
|
0.65%
1/154
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
0.67%
1/150
|
0.00%
0/154
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.67%
1/150
|
0.00%
0/154
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.00%
0/150
|
0.65%
1/154
|
|
Vascular disorders
Arteriosclerosis
|
0.67%
1/150
|
0.00%
0/154
|
|
Vascular disorders
Deep vein thrombosis
|
1.3%
2/150
|
0.00%
0/154
|
|
Vascular disorders
Hypertensive crisis
|
0.67%
1/150
|
0.00%
0/154
|
|
Vascular disorders
Iliac artery stenosis
|
0.67%
1/150
|
0.00%
0/154
|
|
Vascular disorders
Lymphocele
|
0.67%
1/150
|
3.9%
6/154
|
|
Vascular disorders
Lymphorrhoea
|
0.00%
0/150
|
0.65%
1/154
|
|
Vascular disorders
Orthostatic hypotension
|
1.3%
2/150
|
0.00%
0/154
|
Other adverse events
| Measure |
Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen
n=150 participants at risk
In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
|
Standard Mycophenolate Sodium (Myfortic) Dosing Regimen
n=154 participants at risk
In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
26.0%
39/150
|
24.0%
37/154
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.7%
10/150
|
7.1%
11/154
|
|
Cardiac disorders
Tachycardia
|
3.3%
5/150
|
6.5%
10/154
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.3%
8/150
|
1.3%
2/154
|
|
Gastrointestinal disorders
Abdominal distension
|
6.0%
9/150
|
7.8%
12/154
|
|
Gastrointestinal disorders
Abdominal pain
|
8.0%
12/150
|
9.1%
14/154
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.3%
8/150
|
9.7%
15/154
|
|
Gastrointestinal disorders
Constipation
|
38.7%
58/150
|
33.1%
51/154
|
|
Gastrointestinal disorders
Diarrhoea
|
26.7%
40/150
|
17.5%
27/154
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
10/150
|
4.5%
7/154
|
|
Gastrointestinal disorders
Nausea
|
28.7%
43/150
|
24.7%
38/154
|
|
Gastrointestinal disorders
Vomiting
|
19.3%
29/150
|
26.6%
41/154
|
|
General disorders
Fatigue
|
5.3%
8/150
|
1.9%
3/154
|
|
General disorders
Oedema
|
3.3%
5/150
|
7.8%
12/154
|
|
General disorders
Oedema peripheral
|
28.0%
42/150
|
29.9%
46/154
|
|
General disorders
Pain
|
4.7%
7/150
|
5.2%
8/154
|
|
General disorders
Pyrexia
|
12.0%
18/150
|
8.4%
13/154
|
|
Immune system disorders
Kidney transplant rejection
|
2.7%
4/150
|
5.2%
8/154
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
15/150
|
7.1%
11/154
|
|
Infections and infestations
Urinary tract infection
|
30.7%
46/150
|
24.7%
38/154
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
7.3%
11/150
|
9.1%
14/154
|
|
Injury, poisoning and procedural complications
Incision site pain
|
10.7%
16/150
|
11.0%
17/154
|
|
Injury, poisoning and procedural complications
Procedural pain
|
24.0%
36/150
|
20.8%
32/154
|
|
Investigations
Blood creatinine increased
|
9.3%
14/150
|
13.0%
20/154
|
|
Investigations
Cytomegalovirus test positive
|
6.0%
9/150
|
2.6%
4/154
|
|
Investigations
Urine output decreased
|
4.7%
7/150
|
5.2%
8/154
|
|
Investigations
Weight increased
|
0.67%
1/150
|
5.2%
8/154
|
|
Metabolism and nutrition disorders
Dehydration
|
5.3%
8/150
|
2.6%
4/154
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
8.0%
12/150
|
7.8%
12/154
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
5.3%
8/150
|
6.5%
10/154
|
|
Metabolism and nutrition disorders
Fluid overload
|
3.3%
5/150
|
5.8%
9/154
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
6.7%
10/150
|
7.8%
12/154
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.3%
14/150
|
12.3%
19/154
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
16.7%
25/150
|
15.6%
24/154
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
9.3%
14/150
|
9.7%
15/154
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.0%
12/150
|
17.5%
27/154
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
13.3%
20/150
|
7.1%
11/154
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
14.7%
22/150
|
7.8%
12/154
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
11.3%
17/150
|
9.7%
15/154
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
8/150
|
9.1%
14/154
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.0%
3/150
|
5.2%
8/154
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.3%
5/150
|
7.1%
11/154
|
|
Nervous system disorders
Dizziness
|
6.0%
9/150
|
4.5%
7/154
|
|
Nervous system disorders
Headache
|
12.7%
19/150
|
10.4%
16/154
|
|
Nervous system disorders
Paraesthesia
|
4.0%
6/150
|
7.1%
11/154
|
|
Nervous system disorders
Tremor
|
12.7%
19/150
|
13.0%
20/154
|
|
Psychiatric disorders
Anxiety
|
5.3%
8/150
|
7.8%
12/154
|
|
Psychiatric disorders
Insomnia
|
14.0%
21/150
|
14.9%
23/154
|
|
Renal and urinary disorders
Bladder spasm
|
6.0%
9/150
|
5.2%
8/154
|
|
Renal and urinary disorders
Dysuria
|
11.3%
17/150
|
8.4%
13/154
|
|
Renal and urinary disorders
Haematuria
|
10.0%
15/150
|
5.2%
8/154
|
|
Renal and urinary disorders
Renal tubular necrosis
|
6.0%
9/150
|
4.5%
7/154
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
10/150
|
5.2%
8/154
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.0%
9/150
|
8.4%
13/154
|
|
Skin and subcutaneous tissue disorders
Acne
|
6.0%
9/150
|
5.8%
9/154
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
5.3%
8/150
|
3.9%
6/154
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
2.0%
3/150
|
5.2%
8/154
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
3/150
|
5.8%
9/154
|
|
Vascular disorders
Hypertension
|
34.0%
51/150
|
29.2%
45/154
|
|
Vascular disorders
Hypotension
|
7.3%
11/150
|
6.5%
10/154
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER