Trial Outcomes & Findings for Liver Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Sirolimus in Recipients of a Liver Transplant (NCT NCT00118742)
NCT ID: NCT00118742
Last Updated: 2010-08-03
Results Overview
Mean percent change from baseline in estimated glomerular filtration rate (GFR) calculated by modification of diet in renal disease (MDRD)-6 variable equation at 12 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
293 participants
Primary outcome timeframe
12 months posttransplant
Results posted on
2010-08-03
Participant Flow
Patients were recruited from 43 study centers in the US and Canada over a period of 3 years (24-Aug-05 to 03-Jul-08)
Eligible for the study were adult patients (18 to 74 years) who had received a single primary orthotopic liver transplant and were receiving or were scheduled to receive treatment with CellCept® + calcineurin inhibitor (CNI)
Participant milestones
| Measure |
CellCept + CNI (Tacrolimus or Cyclosporine)
CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
|
CellCept + Sirolimus
CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
|
|---|---|---|
|
Overall Study
STARTED
|
145
|
148
|
|
Overall Study
COMPLETED
|
96
|
82
|
|
Overall Study
NOT COMPLETED
|
49
|
66
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Liver Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Sirolimus in Recipients of a Liver Transplant
Baseline characteristics by cohort
| Measure |
CellCept + CNI (Tacrolimus or Cyclosporine)
n=145 Participants
CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
|
CellCept + Sirolimus
n=148 Participants
CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
|
Total
n=293 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
53.4 years
STANDARD_DEVIATION 7.88 • n=5 Participants
|
53.2 years
STANDARD_DEVIATION 8.83 • n=7 Participants
|
53.3 years
STANDARD_DEVIATION 8.36 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
110 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
220 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
3 participants
n=5 Participants
|
11 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
11 participants
n=5 Participants
|
8 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
126 participants
n=5 Participants
|
125 participants
n=7 Participants
|
251 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Height
|
173.6 cm
STANDARD_DEVIATION 10.04 • n=5 Participants
|
173.0 cm
STANDARD_DEVIATION 10.26 • n=7 Participants
|
173.3 cm
STANDARD_DEVIATION 10.14 • n=5 Participants
|
|
Weight
|
79 kg
STANDARD_DEVIATION 16.32 • n=5 Participants
|
77.9 kg
STANDARD_DEVIATION 17.56 • n=7 Participants
|
78.4 kg
STANDARD_DEVIATION 16.94 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 months posttransplantPopulation: intent-to-treat population
Mean percent change from baseline in estimated glomerular filtration rate (GFR) calculated by modification of diet in renal disease (MDRD)-6 variable equation at 12 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.
Outcome measures
| Measure |
CellCept + CNI (Tacrolimus or Cyclosporine)
n=124 Participants
CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
|
CellCept + Sirolimus
n=130 Participants
CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
|
|---|---|---|
|
Change From Baseline in Glomerular Filtration Rate (GFR) at 12 Months Posttransplant
|
1.2 Percent change in GFR (mL/min)
Standard Deviation 39.86
|
19.7 Percent change in GFR (mL/min)
Standard Deviation 40.64
|
SECONDARY outcome
Timeframe: 6 months posttransplantPopulation: intent-to-treat population
Mean percent change from baseline in estimated GFR calculated by modification of diet in renal disease (MDRD)-6 variable equation at 6 and 24 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.
Outcome measures
| Measure |
CellCept + CNI (Tacrolimus or Cyclosporine)
n=145 Participants
CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
|
CellCept + Sirolimus
n=148 Participants
CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
|
|---|---|---|
|
Change From Baseline in Glomerular Filtration Rate (GFR) at 6 Months Posttransplant
|
1.1 Percent change in GFR (mL/min)
Standard Deviation 24.39
|
25.5 Percent change in GFR (mL/min)
Standard Deviation 45.82
|
SECONDARY outcome
Timeframe: 24 months posttransplantPopulation: intent-to-treat population
Mean percent change from baseline in estimated GFR calculated by modification of diet in renal disease (MDRD)-6 variable equation at 6 and 24 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.
Outcome measures
| Measure |
CellCept + CNI (Tacrolimus or Cyclosporine)
n=124 Participants
CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
|
CellCept + Sirolimus
n=130 Participants
CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
|
|---|---|---|
|
Change From Baseline in Glomerular Filtration Rate (GFR) at 24 Months Posttransplant
|
-8.6 Mean percent change in GFR (mL/min)
Standard Deviation 43.37
|
13.5 Mean percent change in GFR (mL/min)
Standard Deviation 49.17
|
SECONDARY outcome
Timeframe: 6, 12, and 24 months posttransplantationPopulation: intent-to-treat population
Mean percent change from baseline in calculated creatinine clearance (CL) at 6, 12, and 24 months posttransplantation
Outcome measures
| Measure |
CellCept + CNI (Tacrolimus or Cyclosporine)
n=145 Participants
CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
|
CellCept + Sirolimus
n=148 Participants
CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
|
|---|---|---|
|
Change From Baseline in Creatinine Clearance
6 months
|
-1.3 Percent change in creatinine CL (mL/min)
Standard Deviation 23.71
|
18.5 Percent change in creatinine CL (mL/min)
Standard Deviation 39.93
|
|
Change From Baseline in Creatinine Clearance
12 months
|
-3.0 Percent change in creatinine CL (mL/min)
Standard Deviation 35.86
|
14.0 Percent change in creatinine CL (mL/min)
Standard Deviation 35.16
|
|
Change From Baseline in Creatinine Clearance
24 months
|
-12.8 Percent change in creatinine CL (mL/min)
Standard Deviation 41.64
|
7.9 Percent change in creatinine CL (mL/min)
Standard Deviation 44.36
|
Adverse Events
CellCept + CNI (Tacrolimus or Cyclosporine)
Serious events: 65 serious events
Other events: 134 other events
Deaths: 0 deaths
CellCept + Sirolimus
Serious events: 67 serious events
Other events: 141 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CellCept + CNI (Tacrolimus or Cyclosporine)
n=146 participants at risk
CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
|
CellCept + Sirolimus
n=148 participants at risk
CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
|
|---|---|---|
|
Infections and infestations
Hepatitis C
|
6.8%
10/146
|
5.4%
8/148
|
|
Infections and infestations
Pneumonia
|
2.1%
3/146
|
1.4%
2/148
|
|
Infections and infestations
Sepsis
|
2.1%
3/146
|
1.4%
2/148
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.68%
1/146
|
2.0%
3/148
|
|
Infections and infestations
Viral Infection
|
0.68%
1/146
|
0.68%
1/148
|
|
Infections and infestations
Abdominal Wall Infection
|
0.00%
0/146
|
0.68%
1/148
|
|
Infections and infestations
Acarodermatitis
|
0.68%
1/146
|
0.00%
0/148
|
|
Infections and infestations
Appendicitis
|
0.00%
0/146
|
0.68%
1/148
|
|
Infections and infestations
Bacteraemia
|
0.68%
1/146
|
0.00%
0/148
|
|
Infections and infestations
Cellulitis
|
0.68%
1/146
|
0.00%
0/148
|
|
Infections and infestations
Clostridial Infection
|
0.68%
1/146
|
0.00%
0/148
|
|
Infections and infestations
Diverticulitis
|
0.68%
1/146
|
0.00%
0/148
|
|
Infections and infestations
Escherichia Urinary Tract Infection
|
0.68%
1/146
|
0.00%
0/148
|
|
Infections and infestations
Influenza
|
0.68%
1/146
|
0.00%
0/148
|
|
Infections and infestations
Lactobacillus Infection
|
0.68%
1/146
|
0.00%
0/148
|
|
Infections and infestations
Liver Abscess
|
0.00%
0/146
|
0.68%
1/148
|
|
Infections and infestations
Lobar Pneumonia
|
0.68%
1/146
|
0.00%
0/148
|
|
Infections and infestations
Pseudomonal Sepsis
|
0.68%
1/146
|
0.00%
0/148
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/146
|
0.68%
1/148
|
|
Infections and infestations
Sinusitis
|
0.00%
0/146
|
0.68%
1/148
|
|
Infections and infestations
Staphylococcal Infection
|
0.68%
1/146
|
0.00%
0/148
|
|
Infections and infestations
Subcutaneous Abscess
|
0.00%
0/146
|
0.68%
1/148
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/146
|
0.68%
1/148
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/146
|
0.68%
1/148
|
|
Infections and infestations
Wound Infection
|
0.00%
0/146
|
0.68%
1/148
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
2/146
|
2.0%
3/148
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/146
|
1.4%
2/148
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
1.4%
2/146
|
0.00%
0/148
|
|
Gastrointestinal disorders
Mouth Ulceration
|
0.00%
0/146
|
1.4%
2/148
|
|
Gastrointestinal disorders
Peritonitis
|
0.68%
1/146
|
0.68%
1/148
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.68%
1/146
|
0.68%
1/148
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.68%
1/146
|
0.00%
0/148
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/146
|
0.68%
1/148
|
|
Gastrointestinal disorders
Crohn's Disease
|
0.68%
1/146
|
0.00%
0/148
|
|
Gastrointestinal disorders
Duodenitis Haemorrhagic
|
0.00%
0/146
|
0.68%
1/148
|
|
Gastrointestinal disorders
Gastritis
|
0.68%
1/146
|
0.00%
0/148
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/146
|
0.68%
1/148
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.68%
1/146
|
0.00%
0/148
|
|
Gastrointestinal disorders
Inguinal Hernia, Obstructive
|
0.00%
0/146
|
0.68%
1/148
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/146
|
0.68%
1/148
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/146
|
0.68%
1/148
|
|
Gastrointestinal disorders
Rectal Ulcer Haemorrhage
|
0.00%
0/146
|
0.68%
1/148
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/146
|
0.68%
1/148
|
|
Injury, poisoning and procedural complications
Incisional Hernia
|
2.7%
4/146
|
2.7%
4/148
|
|
Injury, poisoning and procedural complications
Anastomotic Stenosis
|
0.00%
0/146
|
1.4%
2/148
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.68%
1/146
|
0.68%
1/148
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.68%
1/146
|
0.68%
1/148
|
|
Injury, poisoning and procedural complications
Biliary Anastomosis Complication
|
0.68%
1/146
|
0.00%
0/148
|
|
Injury, poisoning and procedural complications
Complications of Transplanted Kidney
|
0.68%
1/146
|
0.00%
0/148
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.00%
0/146
|
0.68%
1/148
|
|
Injury, poisoning and procedural complications
Graft Loss
|
0.00%
0/146
|
0.68%
1/148
|
|
Injury, poisoning and procedural complications
Meniscus Lesion
|
0.00%
0/146
|
0.68%
1/148
|
|
Injury, poisoning and procedural complications
Post Procedural Haematoma
|
0.00%
0/146
|
0.68%
1/148
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/146
|
0.68%
1/148
|
|
Injury, poisoning and procedural complications
Stress Fracture
|
0.00%
0/146
|
0.68%
1/148
|
|
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
|
0.00%
0/146
|
0.68%
1/148
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/146
|
2.7%
4/148
|
|
Hepatobiliary disorders
Bile Duct Obstruction
|
1.4%
2/146
|
0.00%
0/148
|
|
Hepatobiliary disorders
Bile Duct Stenosis
|
0.68%
1/146
|
0.68%
1/148
|
|
Hepatobiliary disorders
Biliary Tract Disorder
|
0.68%
1/146
|
0.68%
1/148
|
|
Hepatobiliary disorders
Hepatic Artery Thrombosis
|
0.00%
0/146
|
1.4%
2/148
|
|
Hepatobiliary disorders
Autoimmune Hepatitis
|
0.68%
1/146
|
0.00%
0/148
|
|
Hepatobiliary disorders
Cholestasis
|
0.68%
1/146
|
0.00%
0/148
|
|
Hepatobiliary disorders
Haemobilia
|
0.00%
0/146
|
0.68%
1/148
|
|
Hepatobiliary disorders
Hepatic Artery Stenosis
|
0.68%
1/146
|
0.00%
0/148
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.68%
1/146
|
0.00%
0/148
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
0.68%
1/146
|
0.00%
0/148
|
|
Hepatobiliary disorders
Hepatic Infarction
|
0.00%
0/146
|
0.68%
1/148
|
|
Hepatobiliary disorders
Hepatitis Acute
|
0.00%
0/146
|
0.68%
1/148
|
|
Hepatobiliary disorders
Perforation Bile Duct
|
0.00%
0/146
|
0.68%
1/148
|
|
Hepatobiliary disorders
Portal Vein Thrombosis
|
0.68%
1/146
|
0.00%
0/148
|
|
General disorders
Pyrexia
|
0.68%
1/146
|
4.7%
7/148
|
|
General disorders
Chest Pain
|
0.68%
1/146
|
0.68%
1/148
|
|
General disorders
Multi-Organ Failure
|
0.68%
1/146
|
0.68%
1/148
|
|
General disorders
Fat Tissue Increased
|
0.00%
0/146
|
0.68%
1/148
|
|
General disorders
Fatigue
|
0.68%
1/146
|
0.00%
0/148
|
|
General disorders
Hernia
|
0.00%
0/146
|
0.68%
1/148
|
|
General disorders
Hernia Obstructive
|
0.00%
0/146
|
0.68%
1/148
|
|
General disorders
Impaired Healing
|
0.00%
0/146
|
0.68%
1/148
|
|
General disorders
Malaise
|
0.68%
1/146
|
0.00%
0/148
|
|
General disorders
Ulcer Haemorrhage
|
0.00%
0/146
|
0.68%
1/148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Cancer Metastatic
|
1.4%
2/146
|
2.0%
3/148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.68%
1/146
|
0.00%
0/148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-Cell Lymphoma
|
0.68%
1/146
|
0.00%
0/148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Desmoid Tumour
|
0.68%
1/146
|
0.00%
0/148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epstein-Barr Virus Associated Lymphoproliferative Disorder
|
0.68%
1/146
|
0.00%
0/148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal Tract Adenoma
|
0.68%
1/146
|
0.00%
0/148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Neoplasm Malignant
|
0.68%
1/146
|
0.00%
0/148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Small Cell Lung Cancer Metastatic
|
0.68%
1/146
|
0.00%
0/148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
0.00%
0/146
|
0.68%
1/148
|
|
Blood and lymphatic system disorders
Anaemia
|
0.68%
1/146
|
2.7%
4/148
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.4%
2/146
|
0.68%
1/148
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.68%
1/146
|
0.68%
1/148
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.68%
1/146
|
0.68%
1/148
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/146
|
0.68%
1/148
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
2.7%
4/146
|
0.00%
0/148
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.68%
1/146
|
0.68%
1/148
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis Allergic
|
0.00%
0/146
|
0.68%
1/148
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/146
|
0.68%
1/148
|
|
Respiratory, thoracic and mediastinal disorders
Lung Disorder
|
0.68%
1/146
|
0.00%
0/148
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.68%
1/146
|
0.00%
0/148
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.68%
1/146
|
0.00%
0/148
|
|
Vascular disorders
Deep Vein Thrombosis
|
1.4%
2/146
|
2.7%
4/148
|
|
Vascular disorders
Embolism Venous
|
0.68%
1/146
|
0.00%
0/148
|
|
Vascular disorders
Hypertension
|
0.00%
0/146
|
0.68%
1/148
|
|
Vascular disorders
Orthostatic Hypotension
|
0.68%
1/146
|
0.00%
0/148
|
|
Vascular disorders
Vasculitis
|
0.68%
1/146
|
0.00%
0/148
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.7%
4/146
|
0.00%
0/148
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.4%
2/146
|
0.00%
0/148
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/146
|
0.68%
1/148
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.68%
1/146
|
0.00%
0/148
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.68%
1/146
|
0.00%
0/148
|
|
Nervous system disorders
Headache
|
1.4%
2/146
|
0.68%
1/148
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.68%
1/146
|
0.00%
0/148
|
|
Nervous system disorders
Convulsion
|
0.68%
1/146
|
0.00%
0/148
|
|
Nervous system disorders
Encephalopathy
|
0.68%
1/146
|
0.00%
0/148
|
|
Nervous system disorders
Haemorrhage Intracranial
|
0.68%
1/146
|
0.00%
0/148
|
|
Nervous system disorders
Neuralgic Amyotrophy
|
0.00%
0/146
|
0.68%
1/148
|
|
Nervous system disorders
Neuroleptic Malignant Syndrome
|
0.00%
0/146
|
0.68%
1/148
|
|
Cardiac disorders
Atrial Fibrillation
|
0.68%
1/146
|
0.68%
1/148
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.68%
1/146
|
0.68%
1/148
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/146
|
1.4%
2/148
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/146
|
0.68%
1/148
|
|
Cardiac disorders
Atrial Flutter
|
0.68%
1/146
|
0.00%
0/148
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/146
|
0.68%
1/148
|
|
Cardiac disorders
Mitral Valve Incompetence
|
0.00%
0/146
|
0.68%
1/148
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.68%
1/146
|
0.00%
0/148
|
|
Renal and urinary disorders
Renal Failure
|
3.4%
5/146
|
0.00%
0/148
|
|
Renal and urinary disorders
Renal Failure Acute
|
1.4%
2/146
|
0.00%
0/148
|
|
Renal and urinary disorders
Urinary Retention
|
0.68%
1/146
|
0.00%
0/148
|
|
Investigations
Hepatic Enzyme Increased
|
0.00%
0/146
|
1.4%
2/148
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.68%
1/146
|
0.00%
0/148
|
|
Investigations
Blood Creatinine Increased
|
0.68%
1/146
|
0.00%
0/148
|
|
Investigations
Blood Glucose Increased
|
0.68%
1/146
|
0.00%
0/148
|
|
Investigations
Liver Function Test Abnormal
|
0.68%
1/146
|
0.00%
0/148
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.4%
2/146
|
0.00%
0/148
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/146
|
0.68%
1/148
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/146
|
0.68%
1/148
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/146
|
0.68%
1/148
|
|
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
|
0.68%
1/146
|
0.00%
0/148
|
|
Immune system disorders
Transplant Rejection
|
0.68%
1/146
|
0.68%
1/148
|
|
Immune system disorders
Graft Versus Host Disease
|
0.68%
1/146
|
0.00%
0/148
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/146
|
0.68%
1/148
|
|
Immune system disorders
Liver Transplant Rejection
|
0.00%
0/146
|
0.68%
1/148
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
0.00%
0/146
|
1.4%
2/148
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.68%
1/146
|
0.00%
0/148
|
|
Psychiatric disorders
Alcohol Abuse
|
0.00%
0/146
|
0.68%
1/148
|
|
Psychiatric disorders
Confusional State
|
0.68%
1/146
|
0.00%
0/148
|
|
Skin and subcutaneous tissue disorders
Drug Eruption
|
0.00%
0/146
|
0.68%
1/148
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/146
|
0.68%
1/148
|
|
Endocrine disorders
Inappropriate Antidiuretic Hormone Secretion
|
0.68%
1/146
|
0.00%
0/148
|
|
Eye disorders
Cataract
|
0.00%
0/146
|
0.68%
1/148
|
Other adverse events
| Measure |
CellCept + CNI (Tacrolimus or Cyclosporine)
n=146 participants at risk
CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
|
CellCept + Sirolimus
n=148 participants at risk
CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
28.8%
42/146
|
25.0%
37/148
|
|
Gastrointestinal disorders
Abdominal Pain
|
17.8%
26/146
|
14.2%
21/148
|
|
Gastrointestinal disorders
Nausea
|
15.8%
23/146
|
12.8%
19/148
|
|
Gastrointestinal disorders
Vomiting
|
13.7%
20/146
|
8.1%
12/148
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
7.5%
11/146
|
4.7%
7/148
|
|
Gastrointestinal disorders
Constipation
|
6.8%
10/146
|
4.1%
6/148
|
|
Gastrointestinal disorders
Mouth Ulceration
|
0.00%
0/146
|
6.8%
10/148
|
|
Gastrointestinal disorders
Stomatitis
|
0.68%
1/146
|
6.1%
9/148
|
|
Infections and infestations
Hepatitis C
|
15.8%
23/146
|
13.5%
20/148
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.5%
8/146
|
4.7%
7/148
|
|
Infections and infestations
Sinusitis
|
6.8%
10/146
|
2.7%
4/148
|
|
Infections and infestations
Nasopharyngitis
|
4.8%
7/146
|
3.4%
5/148
|
|
General disorders
Pyrexia
|
14.4%
21/146
|
16.9%
25/148
|
|
General disorders
Fatigue
|
15.8%
23/146
|
17.6%
26/148
|
|
General disorders
Oedema Peripheral
|
11.6%
17/146
|
18.2%
27/148
|
|
General disorders
Asthenia
|
4.8%
7/146
|
5.4%
8/148
|
|
Nervous system disorders
Headache
|
16.4%
24/146
|
25.7%
38/148
|
|
Nervous system disorders
Tremor
|
10.3%
15/146
|
8.1%
12/148
|
|
Nervous system disorders
Dizziness
|
7.5%
11/146
|
5.4%
8/148
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.4%
5/146
|
17.6%
26/148
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
8.9%
13/146
|
5.4%
8/148
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
4.1%
6/146
|
7.4%
11/148
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.7%
4/146
|
4.7%
7/148
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.9%
13/146
|
9.5%
14/148
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
10.3%
15/146
|
7.4%
11/148
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
8.2%
12/146
|
6.1%
9/148
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
4.8%
7/146
|
4.7%
7/148
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.7%
4/146
|
5.4%
8/148
|
|
Investigations
Hepatic Enzyme Increased
|
7.5%
11/146
|
8.1%
12/148
|
|
Investigations
Liver Function Test Abnormal
|
6.2%
9/146
|
8.1%
12/148
|
|
Investigations
Weight Increased
|
5.5%
8/146
|
6.1%
9/148
|
|
Investigations
Weight Decreased
|
6.8%
10/146
|
3.4%
5/148
|
|
Investigations
White Blood Cell Count Decreased
|
6.2%
9/146
|
3.4%
5/148
|
|
Investigations
Blood Creatinine Increased
|
6.2%
9/146
|
0.00%
0/148
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
3.4%
5/146
|
10.1%
15/148
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
9.6%
14/146
|
1.4%
2/148
|
|
Metabolism and nutrition disorders
Anorexia
|
4.1%
6/146
|
5.4%
8/148
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.4%
2/146
|
6.8%
10/148
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
5.5%
8/146
|
2.0%
3/148
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.1%
3/146
|
4.7%
7/148
|
|
Blood and lymphatic system disorders
Leukopenia
|
14.4%
21/146
|
23.6%
35/148
|
|
Blood and lymphatic system disorders
Anaemia
|
9.6%
14/146
|
8.8%
13/148
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.5%
11/146
|
4.7%
7/148
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.4%
5/146
|
4.7%
7/148
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.9%
13/146
|
8.8%
13/148
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.8%
10/146
|
6.1%
9/148
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
4.1%
6/146
|
7.4%
11/148
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.1%
6/146
|
4.7%
7/148
|
|
Injury, poisoning and procedural complications
Incisional Hernia
|
2.1%
3/146
|
6.1%
9/148
|
|
Injury, poisoning and procedural complications
Incision Site Pain
|
4.8%
7/146
|
5.4%
8/148
|
|
Psychiatric disorders
Insomnia
|
11.0%
16/146
|
8.8%
13/148
|
|
Psychiatric disorders
Depression
|
5.5%
8/146
|
6.8%
10/148
|
|
Vascular disorders
Hypertension
|
10.3%
15/146
|
10.8%
16/148
|
|
Renal and urinary disorders
Renal Failure
|
4.8%
7/146
|
1.4%
2/148
|
|
Hepatobiliary disorders
Jaundice
|
4.8%
7/146
|
1.4%
2/148
|
Additional Information
Medical Communications
Hoffmann-La Roche
Phone: 800-821-8590
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER