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Trial Outcomes & Findings for Efficacy and Safety of Enteric-coated Mycophenolate Sodium and Cyclosporine in Combination With and Without Steroids, in Adult Renal Transplant Recipients (NCT NCT00413920)

NCT ID: NCT00413920

Last Updated: 2011-04-21

Results Overview

Treatment failures defined as Biopsy Proven Acute Rejection (BPAR), graft loss, death or loss to follow-up. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection. Graft loss: allograft will be presumed to be lost on the day the patient starts dialysis and is not able to subsequently be removed from dialysis.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

222 participants

Primary outcome timeframe

6 months post transplantation

Results posted on

2011-04-21

Participant Flow

Participant milestones

Participant milestones
Measure
Without Steroids
Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
With Steroids
Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
Overall Study
STARTED
112
110
Overall Study
COMPLETED
84
82
Overall Study
NOT COMPLETED
28
28

Reasons for withdrawal

Reasons for withdrawal
Measure
Without Steroids
Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
With Steroids
Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
Overall Study
Adverse Event
9
11
Overall Study
Lack of Efficacy
11
9
Overall Study
Death
3
5
Overall Study
Graft Loss
5
3

Baseline Characteristics

Efficacy and Safety of Enteric-coated Mycophenolate Sodium and Cyclosporine in Combination With and Without Steroids, in Adult Renal Transplant Recipients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Without Steroids
n=112 Participants
Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
With Steroids
n=110 Participants
Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
Total
n=222 Participants
Total of all reporting groups
Age Continuous
51.0 years
STANDARD_DEVIATION 10.24 • n=5 Participants
50.9 years
STANDARD_DEVIATION 11.91 • n=7 Participants
51.0 years
STANDARD_DEVIATION 11.07 • n=5 Participants
Age, Customized
< 45 years
33 Participants
n=5 Participants
25 Participants
n=7 Participants
58 Participants
n=5 Participants
Age, Customized
45-60 years
56 Participants
n=5 Participants
58 Participants
n=7 Participants
114 Participants
n=5 Participants
Age, Customized
>= 60 years
23 Participants
n=5 Participants
27 Participants
n=7 Participants
50 Participants
n=5 Participants
Sex: Female, Male
Female
36 Participants
n=5 Participants
40 Participants
n=7 Participants
76 Participants
n=5 Participants
Sex: Female, Male
Male
76 Participants
n=5 Participants
70 Participants
n=7 Participants
146 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 6 months post transplantation

Population: Intent-to-treat population

Treatment failures defined as Biopsy Proven Acute Rejection (BPAR), graft loss, death or loss to follow-up. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection. Graft loss: allograft will be presumed to be lost on the day the patient starts dialysis and is not able to subsequently be removed from dialysis.

Outcome measures

Outcome measures
Measure
Without Steroids
n=112 Participants
Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
With Steroids
n=110 Participants
Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
Number of Participants With the Occurrence of Treatment Failures at 6 Months Post-transplantation
20 Number of participants
16 Number of participants

SECONDARY outcome

Timeframe: Month 6

Population: Intent-to-treat population

If a participant experienced several BPAR, only the rejection with highest grade is taken into account. Only events that occurred before study treatment discontinuation are taken into account. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection.

Outcome measures

Outcome measures
Measure
Without Steroids
n=112 Participants
Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
With Steroids
n=110 Participants
Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
The Number of Participants With BPAR, Clinical Acute Rejection (AR) and Treated AR at 6 Months
Biopsy Proven Acute Rejection
13 Number of participants
8 Number of participants
The Number of Participants With BPAR, Clinical Acute Rejection (AR) and Treated AR at 6 Months
Graft Loss
5 Number of participants
3 Number of participants
The Number of Participants With BPAR, Clinical Acute Rejection (AR) and Treated AR at 6 Months
Death
2 Number of participants
5 Number of participants
The Number of Participants With BPAR, Clinical Acute Rejection (AR) and Treated AR at 6 Months
Loss to Follow-up
0 Number of participants
0 Number of participants
The Number of Participants With BPAR, Clinical Acute Rejection (AR) and Treated AR at 6 Months
Acute Rejection
37 Number of participants
21 Number of participants
The Number of Participants With BPAR, Clinical Acute Rejection (AR) and Treated AR at 6 Months
Treated Acute Rejection
36 Number of participants
19 Number of participants

SECONDARY outcome

Timeframe: Month 3

Population: Intent-to-treat population

A treatment failure is a Biopsy Proven Acute Rejection (BPAR), a graft loss, a death, or a loss to follow-up. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection. Graft loss: The allograft will be presumed lost on the day the patient starts dialysis and is not able to subsequently be removed from dialysis.

Outcome measures

Outcome measures
Measure
Without Steroids
n=112 Participants
Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
With Steroids
n=110 Participants
Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
Number of Participants With Treatment Failure, BPAR, Clinical Acute Rejection (AR) and Treated AR at 3 Months
Graft Loss
5 Number of participants
1 Number of participants
Number of Participants With Treatment Failure, BPAR, Clinical Acute Rejection (AR) and Treated AR at 3 Months
Death
2 Number of participants
2 Number of participants
Number of Participants With Treatment Failure, BPAR, Clinical Acute Rejection (AR) and Treated AR at 3 Months
Loss to Follow-up
0 Number of participants
0 Number of participants
Number of Participants With Treatment Failure, BPAR, Clinical Acute Rejection (AR) and Treated AR at 3 Months
Acute Rejection
32 Number of participants
19 Number of participants
Number of Participants With Treatment Failure, BPAR, Clinical Acute Rejection (AR) and Treated AR at 3 Months
Treated Acute Rejection
31 Number of participants
16 Number of participants
Number of Participants With Treatment Failure, BPAR, Clinical Acute Rejection (AR) and Treated AR at 3 Months
Biopsy Proven Acute Rejection
10 Number of participants
5 Number of participants
Number of Participants With Treatment Failure, BPAR, Clinical Acute Rejection (AR) and Treated AR at 3 Months
Treatment Failure
17 Number of participants
8 Number of participants

SECONDARY outcome

Timeframe: Month 3

Population: Intent-to-treat population on whom biopsies were performed at 3 months.

The number of participants with subclinical histological rejections was determined by renal biopsy screening at 3 months in 125 patients, providing adequate samples for 112 biopsies.

Outcome measures

Outcome measures
Measure
Without Steroids
n=59 Participants
Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
With Steroids
n=66 Participants
Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
Number of Participants With Subclinical Histological Rejections
BPAR
10 Number of participants
12 Number of participants
Number of Participants With Subclinical Histological Rejections
Sample quality inadequate
7 Number of participants
6 Number of participants
Number of Participants With Subclinical Histological Rejections
Subclinical rejection
12 Number of participants
17 Number of participants
Number of Participants With Subclinical Histological Rejections
Borderline lesions
2 Number of participants
5 Number of participants

SECONDARY outcome

Timeframe: Month 3

Population: Intent-to-treat population. N in the categories is the number of participants from the total population that fit into that category for each arm/group. For example: in the Delayed Graft Function category there were 25 participants in the Without steroid group and 24 participants in the With Steroid Group.

The number of participants with treatment failure defined as a Biopsy Proven Acute Rejection (BPAR), a graft loss, a death, or a loss to follow-up at 3 months by graft recovery status. Delayed graft function is defined as the need for dialysis within the first 7 days post-transplantation, excluding the first post-transplantation day. Slow graft function is defined as a serum creatinine value \> 250 µmol/L at day 5.

Outcome measures

Outcome measures
Measure
Without Steroids
n=112 Participants
Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
With Steroids
n=110 Participants
Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
Number of Participants With Treatment Failure at 3 Months by Graft Recovery Status
Slow Graft Function [N= 36,23]
6 Number of participants
1 Number of participants
Number of Participants With Treatment Failure at 3 Months by Graft Recovery Status
Delayed Graft Function [N= 25,24]
8 Number of participants
4 Number of participants
Number of Participants With Treatment Failure at 3 Months by Graft Recovery Status
Immediate Graft Function [N= 51,63]
3 Number of participants
3 Number of participants

SECONDARY outcome

Timeframe: Months 3 and 6

Outcome measures

Outcome measures
Measure
Without Steroids
n=112 Participants
Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
With Steroids
Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
Number of Participants Requiring Steroids in Non-steroid Treatment Group
6 Months
20 Number of participants
—
Number of Participants Requiring Steroids in Non-steroid Treatment Group
3 Months
25 Number of participants
—

Adverse Events

Without Steroids

Serious events: 72 serious events
Other events: 104 other events
Deaths: 0 deaths

With Steroids

Serious events: 69 serious events
Other events: 107 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Without Steroids
n=112 participants at risk
Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
With Steroids
n=110 participants at risk
Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
Blood and lymphatic system disorders
Agranulocytosis
0.00%
0/112
1.8%
2/110
Blood and lymphatic system disorders
Anaemia
1.8%
2/112
2.7%
3/110
Blood and lymphatic system disorders
Febrile neutropenia
0.00%
0/112
0.91%
1/110
Blood and lymphatic system disorders
Haemoglobinaemia
0.89%
1/112
0.00%
0/110
Blood and lymphatic system disorders
Haemolysis
0.00%
0/112
0.91%
1/110
Blood and lymphatic system disorders
Leukocytosis
0.89%
1/112
0.00%
0/110
Blood and lymphatic system disorders
Leukopenia
0.89%
1/112
3.6%
4/110
Blood and lymphatic system disorders
Neutropenia
0.00%
0/112
3.6%
4/110
Blood and lymphatic system disorders
Normochromic normocytic anaemia
0.89%
1/112
0.00%
0/110
Blood and lymphatic system disorders
Pancytopenia
0.89%
1/112
0.91%
1/110
Cardiac disorders
Acute coronary syndrome
0.89%
1/112
0.00%
0/110
Cardiac disorders
Atrial fibrillation
0.89%
1/112
0.00%
0/110
Cardiac disorders
Cardiac arrest
0.89%
1/112
0.91%
1/110
Cardiac disorders
Coronary artery disease
0.00%
0/112
0.91%
1/110
Cardiac disorders
Myocardial infarction
0.89%
1/112
0.91%
1/110
Cardiac disorders
Pericarditis
0.89%
1/112
0.00%
0/110
Cardiac disorders
Sinus bradycardia
0.89%
1/112
0.00%
0/110
Endocrine disorders
Adrenal insufficiency
0.89%
1/112
0.00%
0/110
Gastrointestinal disorders
Abdominal pain
1.8%
2/112
4.5%
5/110
Gastrointestinal disorders
Abdominal pain lower
0.89%
1/112
0.00%
0/110
Gastrointestinal disorders
Abdominal strangulated hernia
0.00%
0/112
1.8%
2/110
Gastrointestinal disorders
Acute abdomen
0.00%
0/112
0.91%
1/110
Gastrointestinal disorders
Aphthous stomatitis
0.89%
1/112
0.00%
0/110
Gastrointestinal disorders
Colitis
0.89%
1/112
0.91%
1/110
Gastrointestinal disorders
Diarrhoea
4.5%
5/112
5.5%
6/110
Gastrointestinal disorders
Gastric ulcer
0.00%
0/112
0.91%
1/110
Gastrointestinal disorders
Gastric ulcer haemorrhage
0.00%
0/112
0.91%
1/110
Gastrointestinal disorders
Gastroduodenal ulcer
0.89%
1/112
0.00%
0/110
Gastrointestinal disorders
Gastrointestinal disorder
0.89%
1/112
2.7%
3/110
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/112
0.91%
1/110
Gastrointestinal disorders
Haemorrhoids
0.00%
0/112
0.91%
1/110
Gastrointestinal disorders
Ileus
0.00%
0/112
0.91%
1/110
Gastrointestinal disorders
Impaired gastric emptying
0.89%
1/112
0.00%
0/110
Gastrointestinal disorders
Intestinal ischaemia
0.89%
1/112
0.00%
0/110
Gastrointestinal disorders
Intestinal obstruction
0.89%
1/112
1.8%
2/110
Gastrointestinal disorders
Malabsorption
0.89%
1/112
0.00%
0/110
Gastrointestinal disorders
Nausea
0.89%
1/112
0.00%
0/110
Gastrointestinal disorders
Oesophagitis
0.89%
1/112
0.00%
0/110
Gastrointestinal disorders
Pancreatitis acute
0.89%
1/112
0.00%
0/110
Gastrointestinal disorders
Peritonitis
1.8%
2/112
0.00%
0/110
Gastrointestinal disorders
Pneumoperitoneum
0.89%
1/112
0.00%
0/110
Gastrointestinal disorders
Rectal haemorrhage
0.89%
1/112
0.91%
1/110
Gastrointestinal disorders
Stomatitis
0.00%
0/112
0.91%
1/110
Gastrointestinal disorders
Subileus
0.89%
1/112
0.00%
0/110
Gastrointestinal disorders
Vomiting
3.6%
4/112
3.6%
4/110
General disorders
Asthenia
2.7%
3/112
0.00%
0/110
General disorders
Catheter site pain
0.89%
1/112
0.00%
0/110
General disorders
Chills
4.5%
5/112
2.7%
3/110
General disorders
Death
0.00%
0/112
0.91%
1/110
General disorders
General physical health deterioration
0.00%
0/112
0.91%
1/110
General disorders
Hyperthermia
2.7%
3/112
3.6%
4/110
General disorders
Inflammation
0.89%
1/112
0.91%
1/110
General disorders
Oedema peripheral
1.8%
2/112
0.91%
1/110
General disorders
Pain
0.00%
0/112
0.91%
1/110
General disorders
Polyp
0.00%
0/112
0.91%
1/110
General disorders
Pyrexia
8.9%
10/112
9.1%
10/110
General disorders
Sudden death
0.00%
0/112
2.7%
3/110
Hepatobiliary disorders
Cholecystitis acute
0.89%
1/112
0.00%
0/110
Hepatobiliary disorders
Cholestasis
0.89%
1/112
0.00%
0/110
Hepatobiliary disorders
Cytolytic hepatitis
0.89%
1/112
0.91%
1/110
Immune system disorders
Kidney transplant rejection
0.89%
1/112
0.91%
1/110
Immune system disorders
Transplant rejection
0.89%
1/112
0.00%
0/110
Infections and infestations
Acute tonsillitis
0.00%
0/112
0.91%
1/110
Infections and infestations
Bronchitis viral
0.89%
1/112
0.00%
0/110
Infections and infestations
Candidiasis
0.00%
0/112
0.91%
1/110
Infections and infestations
Catheter related infection
0.89%
1/112
0.00%
0/110
Infections and infestations
Cytomegalovirus infection
5.4%
6/112
9.1%
10/110
Infections and infestations
Diarrhoea infectious
0.89%
1/112
0.00%
0/110
Infections and infestations
Gastroenteritis
0.00%
0/112
0.91%
1/110
Infections and infestations
Graft infection
0.00%
0/112
1.8%
2/110
Infections and infestations
Herpes zoster
1.8%
2/112
0.91%
1/110
Infections and infestations
Infected lymphocele
0.00%
0/112
0.91%
1/110
Infections and infestations
Infection
0.00%
0/112
0.91%
1/110
Infections and infestations
Kidney infection
0.00%
0/112
0.91%
1/110
Infections and infestations
Klebsiella sepsis
0.89%
1/112
0.00%
0/110
Infections and infestations
Mycotic aneurysm
0.00%
0/112
0.91%
1/110
Infections and infestations
Nasopharyngitis
0.89%
1/112
0.00%
0/110
Infections and infestations
Nosocomial infection
0.89%
1/112
0.00%
0/110
Infections and infestations
Orchitis
0.00%
0/112
0.91%
1/110
Infections and infestations
Perinephric abscess
0.00%
0/112
0.91%
1/110
Infections and infestations
Pneumonia
0.00%
0/112
0.91%
1/110
Infections and infestations
Pneumonia cytomegaloviral
0.00%
0/112
0.91%
1/110
Infections and infestations
Pyelonephritis
4.5%
5/112
8.2%
9/110
Infections and infestations
Pyelonephritis acute
2.7%
3/112
0.91%
1/110
Infections and infestations
Renal cyst infection
0.89%
1/112
0.00%
0/110
Infections and infestations
Sepsis
1.8%
2/112
2.7%
3/110
Infections and infestations
Staphylococcal infection
0.00%
0/112
0.91%
1/110
Infections and infestations
Staphylococcal sepsis
0.89%
1/112
0.00%
0/110
Infections and infestations
Urinary tract infection
3.6%
4/112
3.6%
4/110
Infections and infestations
Viral infection
0.89%
1/112
0.91%
1/110
Infections and infestations
Wound abscess
0.00%
0/112
0.91%
1/110
Injury, poisoning and procedural complications
Accidental overdose
0.00%
0/112
0.91%
1/110
Injury, poisoning and procedural complications
Arterial injury
0.00%
0/112
0.91%
1/110
Injury, poisoning and procedural complications
Complications of transplanted kidney
2.7%
3/112
3.6%
4/110
Injury, poisoning and procedural complications
Drug toxicity
1.8%
2/112
1.8%
2/110
Injury, poisoning and procedural complications
Graft complication
0.89%
1/112
1.8%
2/110
Injury, poisoning and procedural complications
Graft dysfunction
7.1%
8/112
7.3%
8/110
Injury, poisoning and procedural complications
Graft haemorrhage
0.00%
0/112
0.91%
1/110
Injury, poisoning and procedural complications
Graft thrombosis
2.7%
3/112
0.00%
0/110
Injury, poisoning and procedural complications
Perinephric collection
0.89%
1/112
0.00%
0/110
Injury, poisoning and procedural complications
Perirenal haematoma
0.89%
1/112
1.8%
2/110
Injury, poisoning and procedural complications
Post procedural haematuria
0.89%
1/112
0.00%
0/110
Injury, poisoning and procedural complications
Renal injury
0.89%
1/112
0.00%
0/110
Injury, poisoning and procedural complications
Spinal compression fracture
0.00%
0/112
0.91%
1/110
Injury, poisoning and procedural complications
Therapeutic agent toxicity
4.5%
5/112
0.00%
0/110
Injury, poisoning and procedural complications
Urinary anastomotic leak
0.00%
0/112
0.91%
1/110
Injury, poisoning and procedural complications
Venous injury
0.00%
0/112
0.91%
1/110
Investigations
Blood creatinine increased
8.9%
10/112
7.3%
8/110
Investigations
Creatinine urine increased
0.89%
1/112
0.00%
0/110
Investigations
Immunosuppressant drug level increased
0.89%
1/112
0.00%
0/110
Investigations
Liver function test abnormal
0.89%
1/112
0.00%
0/110
Investigations
Weight decreased
1.8%
2/112
0.91%
1/110
Metabolism and nutrition disorders
Diabetes mellitus
0.00%
0/112
0.91%
1/110
Metabolism and nutrition disorders
Fluid retention
0.00%
0/112
0.91%
1/110
Metabolism and nutrition disorders
Hypercalcaemia
0.89%
1/112
0.00%
0/110
Metabolism and nutrition disorders
Hypercreatininaemia
1.8%
2/112
0.00%
0/110
Metabolism and nutrition disorders
Hyperglycaemia
0.89%
1/112
0.00%
0/110
Metabolism and nutrition disorders
Hyperkalaemia
1.8%
2/112
0.00%
0/110
Metabolism and nutrition disorders
Hypocalcaemia
0.89%
1/112
0.00%
0/110
Metabolism and nutrition disorders
Hypochloraemia
0.00%
0/112
0.91%
1/110
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/112
0.91%
1/110
Metabolism and nutrition disorders
Hyponatraemia
0.89%
1/112
0.91%
1/110
Metabolism and nutrition disorders
Metabolic alkalosis
0.00%
0/112
0.91%
1/110
Metabolism and nutrition disorders
Overweight
0.00%
0/112
0.91%
1/110
Metabolism and nutrition disorders
Sodium retention
0.00%
0/112
0.91%
1/110
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/112
1.8%
2/110
Musculoskeletal and connective tissue disorders
Bone pain
0.00%
0/112
0.91%
1/110
Musculoskeletal and connective tissue disorders
Flank pain
0.89%
1/112
0.00%
0/110
Musculoskeletal and connective tissue disorders
Hypercreatinaemia
0.89%
1/112
0.00%
0/110
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.89%
1/112
0.00%
0/110
Musculoskeletal and connective tissue disorders
Pain in extremity
0.89%
1/112
0.00%
0/110
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
0.00%
0/112
0.91%
1/110
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoproliferative disorder
0.00%
0/112
0.91%
1/110
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage unspecified
0.89%
1/112
0.00%
0/110
Nervous system disorders
Cerebrovascular accident
0.00%
0/112
0.91%
1/110
Nervous system disorders
Headache
0.89%
1/112
0.00%
0/110
Nervous system disorders
Loss of consciousness
0.00%
0/112
0.91%
1/110
Nervous system disorders
Tremor
0.00%
0/112
0.91%
1/110
Psychiatric disorders
Drug abuse
0.89%
1/112
0.00%
0/110
Renal and urinary disorders
Anuria
0.00%
0/112
0.91%
1/110
Renal and urinary disorders
Bladder necrosis
0.00%
0/112
0.91%
1/110
Renal and urinary disorders
Detrusor sphincter dyssynergia
0.89%
1/112
0.00%
0/110
Renal and urinary disorders
Haematuria
0.89%
1/112
0.91%
1/110
Renal and urinary disorders
Hydronephrosis
0.00%
0/112
1.8%
2/110
Renal and urinary disorders
Nephritis
0.89%
1/112
0.00%
0/110
Renal and urinary disorders
Nephropathy
0.89%
1/112
0.00%
0/110
Renal and urinary disorders
Nephropathy toxic
0.89%
1/112
0.91%
1/110
Renal and urinary disorders
Obstructive uropathy
0.00%
0/112
0.91%
1/110
Renal and urinary disorders
Proteinuria
0.89%
1/112
0.00%
0/110
Renal and urinary disorders
Pyelocaliectasis
0.89%
1/112
0.91%
1/110
Renal and urinary disorders
Renal aneurysm
0.00%
0/112
0.91%
1/110
Renal and urinary disorders
Renal artery stenosis
0.89%
1/112
0.00%
0/110
Renal and urinary disorders
Renal artery thrombosis
0.89%
1/112
0.91%
1/110
Renal and urinary disorders
Renal failure
1.8%
2/112
1.8%
2/110
Renal and urinary disorders
Renal failure acute
10.7%
12/112
9.1%
10/110
Renal and urinary disorders
Renal impairment
2.7%
3/112
2.7%
3/110
Renal and urinary disorders
Renal infarct
0.00%
0/112
0.91%
1/110
Renal and urinary disorders
Renal ischaemia
0.00%
0/112
0.91%
1/110
Renal and urinary disorders
Renal tubular disorder
0.89%
1/112
0.00%
0/110
Renal and urinary disorders
Renal tubular necrosis
0.00%
0/112
0.91%
1/110
Renal and urinary disorders
Renal vein thrombosis
0.89%
1/112
0.00%
0/110
Renal and urinary disorders
Ureteral necrosis
0.89%
1/112
0.00%
0/110
Renal and urinary disorders
Ureteric dilatation
1.8%
2/112
0.91%
1/110
Renal and urinary disorders
Ureteric obstruction
0.89%
1/112
0.00%
0/110
Renal and urinary disorders
Ureteric stenosis
4.5%
5/112
1.8%
2/110
Renal and urinary disorders
Urinary bladder haemorrhage
0.00%
0/112
0.91%
1/110
Renal and urinary disorders
Urinary retention
0.89%
1/112
0.91%
1/110
Renal and urinary disorders
Urinary tract obstruction
1.8%
2/112
0.00%
0/110
Renal and urinary disorders
Urinoma
0.89%
1/112
1.8%
2/110
Renal and urinary disorders
Urogenital disorder
0.89%
1/112
0.00%
0/110
Reproductive system and breast disorders
Prostatitis
0.89%
1/112
0.91%
1/110
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
1.8%
2/112
0.91%
1/110
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
0.89%
1/112
0.00%
0/110
Respiratory, thoracic and mediastinal disorders
Aspiration
0.89%
1/112
0.00%
0/110
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/112
1.8%
2/110
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.89%
1/112
0.91%
1/110
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/112
0.91%
1/110
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
0.00%
0/112
0.91%
1/110
Respiratory, thoracic and mediastinal disorders
Lung disorder
0.89%
1/112
0.91%
1/110
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.89%
1/112
0.00%
0/110
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.89%
1/112
0.91%
1/110
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
0.89%
1/112
0.00%
0/110
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
0.89%
1/112
0.00%
0/110
Respiratory, thoracic and mediastinal disorders
Respiratory distress
0.89%
1/112
0.00%
0/110
Skin and subcutaneous tissue disorders
Hyperhidrosis
0.00%
0/112
0.91%
1/110
Skin and subcutaneous tissue disorders
Skin necrosis
0.89%
1/112
0.00%
0/110
Surgical and medical procedures
Catheter removal
0.00%
0/112
0.91%
1/110
Surgical and medical procedures
Nephrectomy
0.89%
1/112
0.00%
0/110
Surgical and medical procedures
Nephrostomy tube removal
0.00%
0/112
0.91%
1/110
Surgical and medical procedures
Transurethral prostatectomy
0.00%
0/112
0.91%
1/110
Surgical and medical procedures
Venous ligation
0.89%
1/112
0.00%
0/110
Vascular disorders
Angiosclerosis
0.89%
1/112
0.00%
0/110
Vascular disorders
Arterial thrombosis
0.89%
1/112
0.00%
0/110
Vascular disorders
Axillary vein thrombosis
0.89%
1/112
0.00%
0/110
Vascular disorders
Circulatory collapse
0.89%
1/112
0.00%
0/110
Vascular disorders
Deep vein thrombosis
0.89%
1/112
0.00%
0/110
Vascular disorders
Extrinsic vascular compression
0.89%
1/112
0.00%
0/110
Vascular disorders
Haematoma
2.7%
3/112
1.8%
2/110
Vascular disorders
Haemorrhage
0.00%
0/112
0.91%
1/110
Vascular disorders
Hypertension
0.00%
0/112
0.91%
1/110
Vascular disorders
Hypotension
0.00%
0/112
0.91%
1/110
Vascular disorders
Lymphocele
2.7%
3/112
4.5%
5/110
Vascular disorders
Orthostatic hypotension
0.89%
1/112
0.00%
0/110
Vascular disorders
Venous thrombosis
0.89%
1/112
0.00%
0/110

Other adverse events

Other adverse events
Measure
Without Steroids
n=112 participants at risk
Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
With Steroids
n=110 participants at risk
Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
Blood and lymphatic system disorders
Anaemia
53.6%
60/112
50.9%
56/110
Blood and lymphatic system disorders
Leukopenia
18.8%
21/112
10.9%
12/110
Gastrointestinal disorders
Abdominal pain
10.7%
12/112
5.5%
6/110
Gastrointestinal disorders
Aphthous stomatitis
3.6%
4/112
5.5%
6/110
Gastrointestinal disorders
Constipation
15.2%
17/112
15.5%
17/110
Gastrointestinal disorders
Diarrhoea
13.4%
15/112
14.5%
16/110
Gastrointestinal disorders
Gastrointestinal disorder
1.8%
2/112
6.4%
7/110
Gastrointestinal disorders
Gingival hypertrophy
7.1%
8/112
7.3%
8/110
General disorders
Oedema peripheral
24.1%
27/112
24.5%
27/110
General disorders
Pain
13.4%
15/112
11.8%
13/110
Hepatobiliary disorders
Cytolytic hepatitis
0.89%
1/112
7.3%
8/110
Infections and infestations
Bronchitis
4.5%
5/112
7.3%
8/110
Infections and infestations
Cytomegalovirus infection
8.0%
9/112
14.5%
16/110
Infections and infestations
Urinary tract infection
30.4%
34/112
35.5%
39/110
Injury, poisoning and procedural complications
Complications of transplanted kidney
7.1%
8/112
8.2%
9/110
Injury, poisoning and procedural complications
Graft dysfunction
14.3%
16/112
16.4%
18/110
Investigations
Blood phosphorus decreased
3.6%
4/112
5.5%
6/110
Metabolism and nutrition disorders
Acidosis
7.1%
8/112
3.6%
4/110
Metabolism and nutrition disorders
Diabetes mellitus
8.9%
10/112
10.0%
11/110
Metabolism and nutrition disorders
Dyslipidaemia
8.9%
10/112
19.1%
21/110
Metabolism and nutrition disorders
Fluid retention
8.0%
9/112
6.4%
7/110
Metabolism and nutrition disorders
Hyperglycaemia
26.8%
30/112
28.2%
31/110
Metabolism and nutrition disorders
Hyperkalaemia
17.0%
19/112
8.2%
9/110
Metabolism and nutrition disorders
Hypocalcaemia
5.4%
6/112
4.5%
5/110
Metabolism and nutrition disorders
Hypokalaemia
9.8%
11/112
15.5%
17/110
Nervous system disorders
Tremor
8.9%
10/112
6.4%
7/110
Psychiatric disorders
Insomnia
17.9%
20/112
16.4%
18/110
Renal and urinary disorders
Haematuria
7.1%
8/112
6.4%
7/110
Renal and urinary disorders
Proteinuria
5.4%
6/112
8.2%
9/110
Vascular disorders
Hypertension
17.9%
20/112
15.5%
17/110
Vascular disorders
Lymphocele
1.8%
2/112
6.4%
7/110

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