Trial Outcomes & Findings for Study Comparing Conversion to Sirolimus vs. Continued Use of Calcineurin Inhibitors in Kidney Transplant Recipients (NCT NCT00038948)
NCT ID: NCT00038948
Last Updated: 2010-05-14
Results Overview
Nankivell GFR: patients with baseline GFR of 20.0 to 40.0 mL/min and patients with baseline GFR of greater than 40.0 mL/min. GFR is an index of kidney function. A higher value means better kidney function.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
830 participants
Primary outcome timeframe
52 weeks
Results posted on
2010-05-14
Participant Flow
Patients were recruited worldwide from January 2002 to September 2003.
Patients were screened for two weeks.
Participant milestones
| Measure |
SRL Conversion in Stable Renal Transplant Recipients
Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy.
|
CNI Continuation in Stable Renal Transplant Recipients
Continued calcineurin inhibitor immunosuppression therapy
|
|---|---|---|
|
Overall Study
STARTED
|
555
|
275
|
|
Overall Study
COMPLETED
|
386
|
198
|
|
Overall Study
NOT COMPLETED
|
169
|
77
|
Reasons for withdrawal
| Measure |
SRL Conversion in Stable Renal Transplant Recipients
Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy.
|
CNI Continuation in Stable Renal Transplant Recipients
Continued calcineurin inhibitor immunosuppression therapy
|
|---|---|---|
|
Overall Study
Adverse Event
|
131
|
43
|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
|
Overall Study
Nonmedical event
|
5
|
7
|
|
Overall Study
Withdrawal by Subject
|
23
|
10
|
|
Overall Study
Protocol Violation
|
3
|
7
|
|
Overall Study
Lack of Efficacy
|
3
|
6
|
Baseline Characteristics
Study Comparing Conversion to Sirolimus vs. Continued Use of Calcineurin Inhibitors in Kidney Transplant Recipients
Baseline characteristics by cohort
| Measure |
SRL Conversion in Stable Renal Transplant Recipients
n=555 Participants
Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy.
|
CNI Continuation in Stable Renal Transplant Recipients
n=275 Participants
Continued calcineurin inhibitor immunosuppression therapy
|
Total
n=830 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
45.00 years
n=5 Participants
|
43.50 years
n=7 Participants
|
44.50 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
170 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
251.0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
385 Participants
n=5 Participants
|
194 Participants
n=7 Participants
|
579.0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: Patients were stratified by GFR at baseline. GFR 20-40 mL/min and GFR \>40 mL/min.
Nankivell GFR: patients with baseline GFR of 20.0 to 40.0 mL/min and patients with baseline GFR of greater than 40.0 mL/min. GFR is an index of kidney function. A higher value means better kidney function.
Outcome measures
| Measure |
SRL Conversion Strata 20.0-40.0 mL/Min
n=58 Participants
Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy in stable renal transplant recipients
|
CNI Continuation Strata 20.0-40.0 mL/Min
n=29 Participants
Continued calcineurin inhibitor immunosuppression therapy in renal transplant recipients.
|
SRL Conversion Strata >40.0 mL/Min
n=496 Participants
Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy in renal transplant recipients.
|
CNI Continuation Strata >40.0 mL/Min
n=245 Participants
Continued calcineurin inhibitor immunosuppression therapy in renal transplant recipients.
|
|---|---|---|---|---|
|
Nankivell Glomerular Filtration Rate (GFR)
|
24.56 mL/min
Standard Error 2.42
|
27.24 mL/min
Standard Error 3.71
|
59.04 mL/min
Standard Error 0.89
|
57.73 mL/min
Standard Error 1.1
|
SECONDARY outcome
Timeframe: 52 and 104 weeksPopulation: Patients were stratified by GFR at baseline. GFR 20-40 mL/min and GFR \>40 mL/min.
Number of patients who experienced for the first time either biopsy-confirmed acute rejection, graft loss, or death by weeks 52 and 104. Assessed by individual endpoint and as composite endpoint (all combined).
Outcome measures
| Measure |
SRL Conversion Strata 20.0-40.0 mL/Min
n=58 Participants
Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy in stable renal transplant recipients
|
CNI Continuation Strata 20.0-40.0 mL/Min
n=29 Participants
Continued calcineurin inhibitor immunosuppression therapy in renal transplant recipients.
|
SRL Conversion Strata >40.0 mL/Min
n=497 Participants
Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy in renal transplant recipients.
|
CNI Continuation Strata >40.0 mL/Min
n=246 Participants
Continued calcineurin inhibitor immunosuppression therapy in renal transplant recipients.
|
|---|---|---|---|---|
|
First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death.
52 weeks - Acute rejection
|
4 patients
|
0 patients
|
8 patients
|
3 patients
|
|
First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death.
52 weeks - Graft loss
|
7 patients
|
3 patients
|
3 patients
|
3 patients
|
|
First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death.
52 weeks - Death
|
3 patients
|
0 patients
|
6 patients
|
1 patients
|
|
First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death.
52 weeks - Missing
|
0 patients
|
0 patients
|
5 patients
|
1 patients
|
|
First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death.
104 weeks - Acute rejection
|
5 patients
|
1 patients
|
27 patients
|
9 patients
|
|
First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death.
104 weeks - Missing
|
0 patients
|
2 patients
|
13 patients
|
8 patients
|
|
First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death.
104 weeks - Graft loss
|
12 patients
|
9 patients
|
12 patients
|
8 patients
|
|
First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death.
104 weeks - Death
|
7 patients
|
0 patients
|
13 patients
|
3 patients
|
Adverse Events
SRL Conversion in Stable Renal Transplant Recipients
Serious events: 81 serious events
Other events: 545 other events
Deaths: 0 deaths
CNI Continuation in Stable Renal Transplant Recipients
Serious events: 45 serious events
Other events: 264 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SRL Conversion in Stable Renal Transplant Recipients
n=551 participants at risk
Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy.
|
CNI Continuation in Stable Renal Transplant Recipients
n=273 participants at risk
Continued calcineurin inhibitor immunosuppression therapy
|
|---|---|---|
|
General disorders
Abdominal pain
|
3.4%
19/551
|
1.8%
5/273
|
|
General disorders
Abdominal syndrome acute
|
0.54%
3/551
|
0.73%
2/273
|
|
General disorders
Abscess
|
1.3%
7/551
|
0.73%
2/273
|
|
General disorders
Accidental injury
|
2.5%
14/551
|
1.1%
3/273
|
|
General disorders
Accidental overdose
|
0.36%
2/551
|
0.37%
1/273
|
|
General disorders
Allergic reaction
|
0.18%
1/551
|
0.00%
0/273
|
|
General disorders
Ascites
|
0.18%
1/551
|
0.00%
0/273
|
|
General disorders
Asthenia
|
0.18%
1/551
|
0.00%
0/273
|
|
General disorders
Back pain
|
0.36%
2/551
|
0.73%
2/273
|
|
General disorders
Carcinoma
|
0.00%
0/551
|
0.37%
1/273
|
|
General disorders
Cellulitis
|
1.8%
10/551
|
1.1%
3/273
|
|
General disorders
Chest pain
|
1.5%
8/551
|
0.73%
2/273
|
|
General disorders
Chills
|
0.91%
5/551
|
0.00%
0/273
|
|
General disorders
Chills and fever
|
0.18%
1/551
|
0.00%
0/273
|
|
General disorders
Cyst
|
0.00%
0/551
|
0.37%
1/273
|
|
General disorders
Drug level increased
|
0.18%
1/551
|
0.00%
0/273
|
|
General disorders
Face edema
|
0.36%
2/551
|
0.00%
0/273
|
|
General disorders
Fever
|
7.8%
43/551
|
3.7%
10/273
|
|
General disorders
Flu syndrome
|
0.73%
4/551
|
0.00%
0/273
|
|
General disorders
Gangrene
|
0.36%
2/551
|
0.00%
0/273
|
|
General disorders
Generalized edema
|
0.54%
3/551
|
0.00%
0/273
|
|
General disorders
Granuloma
|
0.18%
1/551
|
0.00%
0/273
|
|
General disorders
Headache
|
0.18%
1/551
|
0.00%
0/273
|
|
General disorders
Hernia
|
0.91%
5/551
|
0.73%
2/273
|
|
General disorders
Infection
|
7.3%
40/551
|
2.9%
8/273
|
|
General disorders
Lab test abnormal
|
0.54%
3/551
|
0.00%
0/273
|
|
General disorders
Lymphocele
|
0.18%
1/551
|
0.00%
0/273
|
|
General disorders
Moniliasis
|
0.18%
1/551
|
0.00%
0/273
|
|
General disorders
Neck pain
|
0.00%
0/551
|
0.37%
1/273
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/551
|
0.37%
1/273
|
|
General disorders
Overdose
|
0.73%
4/551
|
0.37%
1/273
|
|
General disorders
Pain
|
0.36%
2/551
|
0.37%
1/273
|
|
General disorders
Pelvic pain
|
0.00%
0/551
|
0.37%
1/273
|
|
General disorders
Peritonitis
|
0.36%
2/551
|
0.37%
1/273
|
|
General disorders
Sepsis
|
3.1%
17/551
|
1.8%
5/273
|
|
General disorders
Septic shock
|
0.54%
3/551
|
0.37%
1/273
|
|
General disorders
Suicide attempt
|
0.18%
1/551
|
0.00%
0/273
|
|
General disorders
Transplant rejection
|
3.3%
18/551
|
1.5%
4/273
|
|
Cardiac disorders
Aneurysm
|
0.36%
2/551
|
1.1%
3/273
|
|
Cardiac disorders
Angina pectoris
|
0.36%
2/551
|
0.37%
1/273
|
|
Cardiac disorders
Aortic stenosis
|
0.18%
1/551
|
0.00%
0/273
|
|
Cardiac disorders
Arrhythmia
|
0.18%
1/551
|
0.00%
0/273
|
|
Vascular disorders
Arterial anomaly
|
0.73%
4/551
|
0.37%
1/273
|
|
Cardiac disorders
Arteriosclerosis
|
0.00%
0/551
|
0.37%
1/273
|
|
Cardiac disorders
Atrial fibrillation
|
0.36%
2/551
|
1.1%
3/273
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/551
|
0.37%
1/273
|
|
Cardiac disorders
Bradycardia
|
0.18%
1/551
|
0.00%
0/273
|
|
Cardiac disorders
Cardiac tamponade
|
0.18%
1/551
|
0.00%
0/273
|
|
Cardiac disorders
Cardiomyopathy
|
0.54%
3/551
|
0.00%
0/273
|
|
Cardiac disorders
Cardiovascular disorder
|
0.36%
2/551
|
0.73%
2/273
|
|
Vascular disorders
Cerebral ischemia
|
0.00%
0/551
|
0.73%
2/273
|
|
Vascular disorders
Cerebrovascular accident
|
0.91%
5/551
|
1.1%
3/273
|
|
Cardiac disorders
Congestive heart failure
|
1.1%
6/551
|
0.73%
2/273
|
|
Cardiac disorders
Coronary artery disorder
|
0.54%
3/551
|
0.37%
1/273
|
|
Cardiac disorders
Cyanosis
|
0.18%
1/551
|
0.00%
0/273
|
|
Vascular disorders
Deep vein thrombosis
|
1.5%
8/551
|
1.1%
3/273
|
|
Vascular disorders
Embolus
|
0.18%
1/551
|
0.37%
1/273
|
|
Cardiac disorders
Endocarditis
|
0.18%
1/551
|
0.00%
0/273
|
|
Cardiac disorders
Heart arrest
|
1.1%
6/551
|
0.73%
2/273
|
|
Cardiac disorders
Heart failure
|
0.91%
5/551
|
0.37%
1/273
|
|
Vascular disorders
Hemorrhage
|
0.36%
2/551
|
0.37%
1/273
|
|
Cardiac disorders
Hypertension
|
2.4%
13/551
|
1.5%
4/273
|
|
Vascular disorders
Hypervolemia
|
0.91%
5/551
|
0.37%
1/273
|
|
Cardiac disorders
Hypotension
|
0.18%
1/551
|
1.1%
3/273
|
|
Vascular disorders
Hypovolemia
|
0.54%
3/551
|
0.37%
1/273
|
|
Cardiac disorders
Infarct
|
0.00%
0/551
|
0.37%
1/273
|
|
Cardiac disorders
Migraine
|
0.18%
1/551
|
0.00%
0/273
|
|
Cardiac disorders
Myocardial infarct
|
0.36%
2/551
|
0.00%
0/273
|
|
Vascular disorders
Occlusion
|
0.18%
1/551
|
0.00%
0/273
|
|
Cardiac disorders
Pericardial effusion
|
0.36%
2/551
|
0.00%
0/273
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/551
|
0.73%
2/273
|
|
Vascular disorders
Peripherial gangrene
|
0.36%
2/551
|
0.37%
1/273
|
|
Vascular disorders
Peripherial vascual disorder
|
1.1%
6/551
|
1.5%
4/273
|
|
Vascular disorders
Phlebitis
|
0.18%
1/551
|
0.00%
0/273
|
|
Cardiac disorders
Pulmonary embolus
|
0.54%
3/551
|
0.37%
1/273
|
|
Cardiac disorders
Shock
|
0.73%
4/551
|
0.00%
0/273
|
|
Vascular disorders
Subarachnoid hemorrhage
|
0.36%
2/551
|
0.00%
0/273
|
|
Cardiac disorders
Syncope
|
0.18%
1/551
|
0.00%
0/273
|
|
Vascular disorders
Thrombophlebitis
|
0.73%
4/551
|
1.1%
3/273
|
|
Vascular disorders
Thrombosis
|
0.36%
2/551
|
1.1%
3/273
|
|
Cardiac disorders
Valvular heart disease
|
0.18%
1/551
|
0.00%
0/273
|
|
Vascular disorders
Vascular disorder
|
0.36%
2/551
|
0.00%
0/273
|
|
Gastrointestinal disorders
Anorexia
|
0.18%
1/551
|
0.00%
0/273
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.54%
3/551
|
0.00%
0/273
|
|
Gastrointestinal disorders
Bloody diarrhea
|
0.18%
1/551
|
0.00%
0/273
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma of the mouth
|
0.18%
1/551
|
0.00%
0/273
|
|
Gastrointestinal disorders
Cholelithiasis
|
0.54%
3/551
|
0.37%
1/273
|
|
Gastrointestinal disorders
Colitis
|
1.5%
8/551
|
0.37%
1/273
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/551
|
0.37%
1/273
|
|
Gastrointestinal disorders
Diarrhea
|
6.5%
36/551
|
1.1%
3/273
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/551
|
0.37%
1/273
|
|
Gastrointestinal disorders
Dyspepsia
|
0.18%
1/551
|
0.00%
0/273
|
|
Gastrointestinal disorders
Dysphagia
|
0.18%
1/551
|
0.00%
0/273
|
|
Gastrointestinal disorders
Enterocolitits
|
0.18%
1/551
|
0.00%
0/273
|
|
Gastrointestinal disorders
Esophageal hemorrhage
|
0.18%
1/551
|
0.00%
0/273
|
|
Gastrointestinal disorders
Esophagitis
|
0.36%
2/551
|
0.37%
1/273
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/551
|
0.37%
1/273
|
|
Gastrointestinal disorders
Gastritis
|
0.91%
5/551
|
0.00%
0/273
|
|
Gastrointestinal disorders
Gastroenteritis
|
5.1%
28/551
|
1.5%
4/273
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.18%
1/551
|
0.37%
1/273
|
|
Gastrointestinal disorders
Gastrointestinal disorder general
|
0.54%
3/551
|
0.73%
2/273
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.54%
3/551
|
0.37%
1/273
|
|
Gastrointestinal disorders
Hematemesis
|
0.18%
1/551
|
0.00%
0/273
|
|
Hepatobiliary disorders
Hepatic failure
|
0.18%
1/551
|
0.00%
0/273
|
|
Hepatobiliary disorders
Hepatitis
|
0.18%
1/551
|
0.00%
0/273
|
|
Hepatobiliary disorders
Hepatosplenomegaly
|
0.00%
0/551
|
0.37%
1/273
|
|
Gastrointestinal disorders
Ileus
|
0.36%
2/551
|
0.00%
0/273
|
|
Gastrointestinal disorders
Intestinal nercosis
|
0.18%
1/551
|
0.00%
0/273
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.36%
2/551
|
0.37%
1/273
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.18%
1/551
|
0.00%
0/273
|
|
Gastrointestinal disorders
Intestinal ulcer
|
0.18%
1/551
|
0.00%
0/273
|
|
Hepatobiliary disorders
Liver damage
|
0.18%
1/551
|
0.00%
0/273
|
|
Hepatobiliary disorders
Liver function tests abnormal
|
1.5%
8/551
|
0.00%
0/273
|
|
Hepatobiliary disorders
Liver tenderness
|
0.18%
1/551
|
0.00%
0/273
|
|
Gastrointestinal disorders
Melena
|
0.18%
1/551
|
0.00%
0/273
|
|
Gastrointestinal disorders
Mouth ulcerations
|
0.36%
2/551
|
0.00%
0/273
|
|
Gastrointestinal disorders
Nausea
|
1.6%
9/551
|
0.37%
1/273
|
|
Gastrointestinal disorders
Nausea and vomiting
|
0.00%
0/551
|
0.73%
2/273
|
|
Gastrointestinal disorders
Oral moniliasis
|
0.18%
1/551
|
0.00%
0/273
|
|
Hepatobiliary disorders
Pancreatitis
|
0.36%
2/551
|
0.37%
1/273
|
|
Gastrointestinal disorders
Rectal disorder
|
0.36%
2/551
|
0.00%
0/273
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.36%
2/551
|
0.37%
1/273
|
|
Gastrointestinal disorders
Stomatitis
|
0.18%
1/551
|
0.00%
0/273
|
|
Gastrointestinal disorders
Ulcerative colitis
|
0.18%
1/551
|
0.00%
0/273
|
|
Gastrointestinal disorders
Ulcerative proctitis
|
0.18%
1/551
|
0.00%
0/273
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
9/551
|
1.1%
3/273
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.73%
4/551
|
1.1%
3/273
|
|
Metabolism and nutrition disorders
Parathyroid disorder
|
0.73%
4/551
|
1.1%
3/273
|
|
Blood and lymphatic system disorders
Anemia
|
3.8%
21/551
|
1.1%
3/273
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Aplastic anemia
|
0.18%
1/551
|
0.00%
0/273
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic leukemia
|
0.18%
1/551
|
0.00%
0/273
|
|
Blood and lymphatic system disorders
Hemolytic anemia
|
0.18%
1/551
|
0.00%
0/273
|
|
Blood and lymphatic system disorders
International normalized ratio increased
|
0.18%
1/551
|
0.00%
0/273
|
|
Blood and lymphatic system disorders
Iron deficiency anemia
|
0.18%
1/551
|
0.00%
0/273
|
|
Blood and lymphatic system disorders
Luekocytosis
|
0.18%
1/551
|
0.00%
0/273
|
|
Blood and lymphatic system disorders
Luekopenia
|
0.73%
4/551
|
0.00%
0/273
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphadenopathy
|
0.00%
0/551
|
0.37%
1/273
|
|
Blood and lymphatic system disorders
Lymphoma like reaction
|
0.73%
4/551
|
0.00%
0/273
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.18%
1/551
|
0.00%
0/273
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.36%
2/551
|
0.00%
0/273
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.54%
3/551
|
0.00%
0/273
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.18%
1/551
|
0.00%
0/273
|
|
Metabolism and nutrition disorders
Blood uria nitrogren increased
|
1.6%
9/551
|
1.1%
3/273
|
|
Metabolism and nutrition disorders
Acidosis
|
0.36%
2/551
|
0.00%
0/273
|
|
Metabolism and nutrition disorders
Amyloidosis
|
0.18%
1/551
|
0.00%
0/273
|
|
Metabolism and nutrition disorders
Calcium disorder
|
0.18%
1/551
|
0.00%
0/273
|
|
Metabolism and nutrition disorders
Creatinine increased
|
6.5%
36/551
|
3.3%
9/273
|
|
Metabolism and nutrition disorders
Dehydration
|
2.5%
14/551
|
1.1%
3/273
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.36%
2/551
|
0.73%
2/273
|
|
Metabolism and nutrition disorders
Edema
|
0.54%
3/551
|
0.00%
0/273
|
|
Metabolism and nutrition disorders
Electrolyte abnormality
|
0.18%
1/551
|
0.00%
0/273
|
|
Metabolism and nutrition disorders
Gout
|
0.18%
1/551
|
0.00%
0/273
|
|
Metabolism and nutrition disorders
Healing abnormal
|
0.91%
5/551
|
1.1%
3/273
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/551
|
0.73%
2/273
|
|
Metabolism and nutrition disorders
Hypercholesteremia
|
0.18%
1/551
|
0.00%
0/273
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.36%
2/551
|
0.73%
2/273
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.18%
1/551
|
0.00%
0/273
|
|
Metabolism and nutrition disorders
Hyperlipemia
|
0.54%
3/551
|
0.00%
0/273
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.18%
1/551
|
0.00%
0/273
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.18%
1/551
|
0.00%
0/273
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/551
|
0.73%
2/273
|
|
Metabolism and nutrition disorders
Peripheral edema
|
1.6%
9/551
|
0.73%
2/273
|
|
Metabolism and nutrition disorders
Respiratory acidosis
|
0.18%
1/551
|
0.00%
0/273
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.73%
4/551
|
0.37%
1/273
|
|
Musculoskeletal and connective tissue disorders
Arthrosis
|
0.18%
1/551
|
0.37%
1/273
|
|
Musculoskeletal and connective tissue disorders
Bone necrosis
|
1.1%
6/551
|
0.00%
0/273
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.18%
1/551
|
0.00%
0/273
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
0.18%
1/551
|
0.00%
0/273
|
|
Musculoskeletal and connective tissue disorders
Joint disorder
|
0.18%
1/551
|
0.37%
1/273
|
|
Musculoskeletal and connective tissue disorders
Myasthenia
|
0.00%
0/551
|
0.37%
1/273
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/551
|
0.37%
1/273
|
|
Musculoskeletal and connective tissue disorders
Necrotising faciitis
|
0.18%
1/551
|
0.00%
0/273
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/551
|
0.37%
1/273
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.36%
2/551
|
0.00%
0/273
|
|
Nervous system disorders
Central nervous system anomaly
|
0.00%
0/551
|
0.37%
1/273
|
|
Nervous system disorders
Agitation
|
0.18%
1/551
|
0.00%
0/273
|
|
Nervous system disorders
Confusion
|
0.36%
2/551
|
0.37%
1/273
|
|
Nervous system disorders
Convulsion
|
0.18%
1/551
|
0.73%
2/273
|
|
Nervous system disorders
Depression
|
0.36%
2/551
|
0.00%
0/273
|
|
Nervous system disorders
Encephalopathy
|
0.18%
1/551
|
0.00%
0/273
|
|
Nervous system disorders
Hostility
|
0.18%
1/551
|
0.00%
0/273
|
|
Nervous system disorders
Meningitis
|
0.36%
2/551
|
0.00%
0/273
|
|
Nervous system disorders
Nerve root compression
|
0.00%
0/551
|
0.37%
1/273
|
|
Nervous system disorders
Neuralgia
|
0.36%
2/551
|
0.00%
0/273
|
|
Nervous system disorders
Neuropathy
|
0.36%
2/551
|
0.00%
0/273
|
|
Nervous system disorders
Somnolence
|
0.18%
1/551
|
0.00%
0/273
|
|
Nervous system disorders
Vocal chord paralysis
|
0.18%
1/551
|
0.00%
0/273
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
0.00%
0/551
|
0.37%
1/273
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration pneumonia
|
0.18%
1/551
|
0.00%
0/273
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.18%
1/551
|
0.00%
0/273
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
1.6%
9/551
|
1.1%
3/273
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma of the lung
|
0.00%
0/551
|
0.37%
1/273
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive airway disease
|
0.18%
1/551
|
0.00%
0/273
|
|
Respiratory, thoracic and mediastinal disorders
Cough increased
|
0.36%
2/551
|
0.00%
0/273
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.4%
13/551
|
1.1%
3/273
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.36%
2/551
|
0.00%
0/273
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.18%
1/551
|
0.00%
0/273
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial pneumonia
|
0.36%
2/551
|
0.00%
0/273
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
1.3%
7/551
|
0.37%
1/273
|
|
Respiratory, thoracic and mediastinal disorders
Lung edema
|
0.36%
2/551
|
0.00%
0/273
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.54%
3/551
|
0.00%
0/273
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinitis
|
0.18%
1/551
|
0.00%
0/273
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
1.3%
7/551
|
0.73%
2/273
|
|
Respiratory, thoracic and mediastinal disorders
Plural effusion
|
1.3%
7/551
|
0.37%
1/273
|
|
Respiratory, thoracic and mediastinal disorders
Pluritic pain
|
0.18%
1/551
|
0.00%
0/273
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
10.3%
57/551
|
4.0%
11/273
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.91%
5/551
|
0.00%
0/273
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.18%
1/551
|
0.37%
1/273
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder general
|
0.18%
1/551
|
0.00%
0/273
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.36%
2/551
|
0.37%
1/273
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
0.00%
0/551
|
0.37%
1/273
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.73%
4/551
|
0.37%
1/273
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.36%
2/551
|
0.37%
1/273
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.18%
1/551
|
0.00%
0/273
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.18%
1/551
|
0.00%
0/273
|
|
Skin and subcutaneous tissue disorders
Exfoliative dermatitis
|
0.36%
2/551
|
0.00%
0/273
|
|
Skin and subcutaneous tissue disorders
Fungal dermatitis
|
0.18%
1/551
|
0.00%
0/273
|
|
Skin and subcutaneous tissue disorders
Herpes simplex
|
0.91%
5/551
|
0.00%
0/273
|
|
Skin and subcutaneous tissue disorders
Herpes zoster
|
1.1%
6/551
|
0.73%
2/273
|
|
Skin and subcutaneous tissue disorders
Maculopapular rash
|
0.18%
1/551
|
0.00%
0/273
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.36%
2/551
|
0.00%
0/273
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.73%
4/551
|
0.37%
1/273
|
|
Skin and subcutaneous tissue disorders
Skin benign neoplasm
|
0.00%
0/551
|
0.37%
1/273
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin carcinoma
|
1.3%
7/551
|
5.5%
15/273
|
|
Skin and subcutaneous tissue disorders
Skin disorder general
|
0.36%
2/551
|
0.73%
2/273
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin granuloma
|
0.18%
1/551
|
0.00%
0/273
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin melanoma
|
0.00%
0/551
|
0.73%
2/273
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.73%
4/551
|
0.00%
0/273
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
1.3%
7/551
|
0.37%
1/273
|
|
Skin and subcutaneous tissue disorders
Sweating
|
0.18%
1/551
|
0.00%
0/273
|
|
Eye disorders
Cataract specified
|
0.18%
1/551
|
0.00%
0/273
|
|
Ear and labyrinth disorders
Otitis externa
|
0.18%
1/551
|
0.00%
0/273
|
|
Ear and labyrinth disorders
Otitis media
|
0.54%
3/551
|
0.00%
0/273
|
|
Eye disorders
Parosmia
|
0.18%
1/551
|
0.00%
0/273
|
|
Renal and urinary disorders
Acute kidney failure
|
2.0%
11/551
|
1.5%
4/273
|
|
Renal and urinary disorders
Albuminuria
|
1.5%
8/551
|
0.37%
1/273
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/551
|
0.37%
1/273
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast carcinoma
|
0.00%
0/551
|
0.37%
1/273
|
|
Reproductive system and breast disorders
Breast enlargement
|
0.18%
1/551
|
0.00%
0/273
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/551
|
0.37%
1/273
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
0.00%
0/551
|
0.37%
1/273
|
|
Renal and urinary disorders
Dysuria
|
0.18%
1/551
|
0.00%
0/273
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial carcinoma
|
0.00%
0/551
|
0.37%
1/273
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.18%
1/551
|
0.00%
0/273
|
|
Renal and urinary disorders
Glomerulitis
|
0.91%
5/551
|
0.73%
2/273
|
|
Renal and urinary disorders
Hematuria
|
0.54%
3/551
|
0.00%
0/273
|
|
Renal and urinary disorders
Hydronephrosis
|
1.1%
6/551
|
0.00%
0/273
|
|
Renal and urinary disorders
Hydroureter
|
0.00%
0/551
|
0.37%
1/273
|
|
Renal and urinary disorders
Kidney calculus
|
0.18%
1/551
|
0.00%
0/273
|
|
Renal and urinary disorders
Kidney failure
|
2.4%
13/551
|
3.3%
9/273
|
|
Renal and urinary disorders
Kidney function abnormal
|
5.3%
29/551
|
6.6%
18/273
|
|
Renal and urinary disorders
Kidney tubular disorder
|
0.18%
1/551
|
0.00%
0/273
|
|
Renal and urinary disorders
Kidney tubular necrosis
|
0.00%
0/551
|
0.37%
1/273
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.54%
3/551
|
0.37%
1/273
|
|
Renal and urinary disorders
Metrorrhagia
|
0.54%
3/551
|
0.37%
1/273
|
|
Renal and urinary disorders
Nephritis
|
0.54%
3/551
|
0.37%
1/273
|
|
Renal and urinary disorders
Nephrosclerosis
|
0.54%
3/551
|
0.00%
0/273
|
|
Renal and urinary disorders
Nephrosis
|
1.6%
9/551
|
0.00%
0/273
|
|
Renal and urinary disorders
Oliguria
|
0.36%
2/551
|
0.00%
0/273
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cyst
|
0.73%
4/551
|
0.00%
0/273
|
|
Renal and urinary disorders
Polycystic kidney
|
0.18%
1/551
|
0.00%
0/273
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic carcinoma
|
0.54%
3/551
|
0.73%
2/273
|
|
Renal and urinary disorders
Pyelonephritis
|
2.2%
12/551
|
1.5%
4/273
|
|
Renal and urinary disorders
Scrotal edema
|
0.18%
1/551
|
0.00%
0/273
|
|
Renal and urinary disorders
Toxic nephropathy
|
0.18%
1/551
|
0.00%
0/273
|
|
Reproductive system and breast disorders
Unintended pregnancy
|
0.18%
1/551
|
0.37%
1/273
|
|
Renal and urinary disorders
Uremia
|
0.73%
4/551
|
0.00%
0/273
|
|
Renal and urinary disorders
Urinary frequency
|
0.18%
1/551
|
0.00%
0/273
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.36%
2/551
|
0.37%
1/273
|
|
Renal and urinary disorders
Urinary tract infection
|
6.0%
33/551
|
4.4%
12/273
|
|
Injury, poisoning and procedural complications
Local reaction to procedure
|
2.9%
16/551
|
2.6%
7/273
|
|
General disorders
Device malfunction
|
0.54%
3/551
|
0.00%
0/273
|
|
General disorders
Other etiology unknown
|
0.00%
0/551
|
0.73%
2/273
|
|
Gastrointestinal disorders
Cholecystitis
|
0.18%
1/551
|
0.00%
0/273
|
|
Hepatobiliary disorders
Pancreas disorder
|
0.18%
1/551
|
0.37%
1/273
|
Other adverse events
| Measure |
SRL Conversion in Stable Renal Transplant Recipients
n=551 participants at risk
Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy.
|
CNI Continuation in Stable Renal Transplant Recipients
n=273 participants at risk
Continued calcineurin inhibitor immunosuppression therapy
|
|---|---|---|
|
General disorders
Abdominal pain
|
15.8%
87/551
|
15.4%
42/273
|
|
General disorders
Accidental injury
|
17.8%
98/551
|
14.3%
39/273
|
|
General disorders
Asthenia
|
13.6%
75/551
|
11.0%
30/273
|
|
General disorders
Back pain
|
8.3%
46/551
|
13.6%
37/273
|
|
General disorders
Chest pain
|
7.6%
42/551
|
8.4%
23/273
|
|
General disorders
Cyst
|
5.4%
30/551
|
4.8%
13/273
|
|
General disorders
Face edema
|
5.8%
32/551
|
0.73%
2/273
|
|
General disorders
Fever
|
22.7%
125/551
|
10.3%
28/273
|
|
General disorders
Flu syndrome
|
4.5%
25/551
|
5.1%
14/273
|
|
General disorders
Headache
|
20.1%
111/551
|
15.8%
43/273
|
|
General disorders
Lab test abnormal
|
6.9%
38/551
|
5.5%
15/273
|
|
General disorders
Pain
|
14.9%
82/551
|
13.9%
38/273
|
|
General disorders
Transplant rejection
|
5.8%
32/551
|
5.1%
14/273
|
|
Cardiac disorders
Hypertension
|
23.0%
127/551
|
24.9%
68/273
|
|
Gastrointestinal disorders
Anorexia
|
6.0%
33/551
|
4.0%
11/273
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
8.9%
49/551
|
1.1%
3/273
|
|
Gastrointestinal disorders
Constipation
|
5.8%
32/551
|
5.5%
15/273
|
|
Gastrointestinal disorders
Diarrhea
|
42.5%
234/551
|
27.5%
75/273
|
|
Gastrointestinal disorders
Dyspepsia
|
6.4%
35/551
|
7.7%
21/273
|
|
Gastrointestinal disorders
Gastritis
|
3.8%
21/551
|
5.1%
14/273
|
|
Gastrointestinal disorders
Gum hyperplasia
|
0.18%
1/551
|
5.5%
15/273
|
|
Gastrointestinal disorders
Liver function tests abnormal
|
6.9%
38/551
|
1.5%
4/273
|
|
Gastrointestinal disorders
Mouth ulceration
|
6.2%
34/551
|
0.37%
1/273
|
|
Gastrointestinal disorders
Nausea
|
12.5%
69/551
|
9.9%
27/273
|
|
Gastrointestinal disorders
Stomatitis
|
10.7%
59/551
|
1.1%
3/273
|
|
Gastrointestinal disorders
Vomiting
|
13.1%
72/551
|
13.9%
38/273
|
|
Endocrine disorders
Diabetes mellitus
|
6.0%
33/551
|
4.4%
12/273
|
|
Blood and lymphatic system disorders
Anemia
|
39.7%
219/551
|
22.3%
61/273
|
|
Blood and lymphatic system disorders
Ecchymosis
|
5.1%
28/551
|
1.8%
5/273
|
|
Blood and lymphatic system disorders
Iron deficiency anemia
|
5.8%
32/551
|
1.1%
3/273
|
|
Blood and lymphatic system disorders
Leukopenia
|
13.6%
75/551
|
4.8%
13/273
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.3%
79/551
|
3.7%
10/273
|
|
Metabolism and nutrition disorders
Acidosis
|
5.1%
28/551
|
5.5%
15/273
|
|
Metabolism and nutrition disorders
BUN increased
|
6.2%
34/551
|
4.8%
13/273
|
|
Metabolism and nutrition disorders
Creatinine increased
|
20.5%
113/551
|
17.6%
48/273
|
|
Metabolism and nutrition disorders
Dehydration
|
6.4%
35/551
|
2.2%
6/273
|
|
Metabolism and nutrition disorders
Edema
|
11.3%
62/551
|
6.6%
18/273
|
|
Metabolism and nutrition disorders
Gout
|
5.3%
29/551
|
5.5%
15/273
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.91%
5/551
|
5.5%
15/273
|
|
Metabolism and nutrition disorders
Hypercholesteremia
|
44.5%
245/551
|
16.1%
44/273
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
13.8%
76/551
|
7.3%
20/273
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.4%
13/551
|
7.0%
19/273
|
|
Metabolism and nutrition disorders
Hyperlipemia
|
57.5%
317/551
|
30.4%
83/273
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
8.3%
46/551
|
17.6%
48/273
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.3%
57/551
|
2.9%
8/273
|
|
Metabolism and nutrition disorders
Lactic dehydrogenase increased
|
12.7%
70/551
|
2.2%
6/273
|
|
Metabolism and nutrition disorders
Peripheral edema
|
34.5%
190/551
|
18.7%
51/273
|
|
Metabolism and nutrition disorders
SGOT increased
|
7.6%
42/551
|
0.73%
2/273
|
|
Metabolism and nutrition disorders
SGPT increased
|
8.5%
47/551
|
1.5%
4/273
|
|
Metabolism and nutrition disorders
Weight loss
|
5.3%
29/551
|
4.0%
11/273
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.5%
91/551
|
20.1%
55/273
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.9%
38/551
|
4.4%
12/273
|
|
Nervous system disorders
Anxiety
|
5.1%
28/551
|
1.8%
5/273
|
|
Nervous system disorders
Depression
|
5.6%
31/551
|
5.1%
14/273
|
|
Nervous system disorders
Dizziness
|
6.7%
37/551
|
5.9%
16/273
|
|
Nervous system disorders
Insomnia
|
7.1%
39/551
|
5.9%
16/273
|
|
Respiratory, thoracic and mediastinal disorders
Cough increased
|
18.1%
100/551
|
14.7%
40/273
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.8%
54/551
|
8.1%
22/273
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.4%
52/551
|
1.5%
4/273
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
13.6%
75/551
|
9.9%
27/273
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
8.7%
48/551
|
6.6%
18/273
|
|
Skin and subcutaneous tissue disorders
Acne
|
16.9%
93/551
|
4.0%
11/273
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
34/551
|
1.8%
5/273
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.2%
73/551
|
5.1%
14/273
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
4.7%
26/551
|
6.6%
18/273
|
|
Renal and urinary disorders
Albuminuria
|
30.1%
166/551
|
16.5%
45/273
|
|
Renal and urinary disorders
Amenorrhea
|
8.9%
15/168
|
1.2%
1/81
|
|
Renal and urinary disorders
Dysuria
|
5.4%
30/551
|
3.7%
10/273
|
|
Renal and urinary disorders
Hematuria
|
6.0%
33/551
|
4.0%
11/273
|
|
Renal and urinary disorders
Impotence
|
6.3%
24/383
|
3.6%
7/192
|
|
Renal and urinary disorders
Kidney function abnormal
|
13.2%
73/551
|
17.2%
47/273
|
|
Renal and urinary disorders
Menorrhagia
|
7.1%
12/168
|
2.5%
2/81
|
|
Renal and urinary disorders
Metrorrhagia
|
7.1%
12/168
|
6.2%
5/81
|
|
Reproductive system and breast disorders
Ovarian cyst
|
8.3%
14/168
|
4.9%
4/81
|
|
Injury, poisoning and procedural complications
Local reaction to procedure
|
7.6%
42/551
|
9.2%
25/273
|
|
General disorders
Cellulitis
|
5.6%
31/551
|
2.2%
6/273
|
|
General disorders
Flu Syndrome
|
11.3%
62/551
|
11.0%
30/273
|
|
General disorders
Infection
|
32.1%
177/551
|
26.0%
71/273
|
|
General disorders
Sepsis
|
5.1%
28/551
|
2.2%
6/273
|
|
Gastrointestinal disorders
Gastroenteritis
|
12.3%
68/551
|
8.1%
22/273
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
9.3%
51/551
|
6.2%
17/273
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
16.0%
88/551
|
6.2%
17/273
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
8.9%
49/551
|
9.2%
25/273
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
19.1%
105/551
|
17.9%
49/273
|
|
Skin and subcutaneous tissue disorders
Fungal Dermatitis
|
8.7%
48/551
|
5.9%
16/273
|
|
Skin and subcutaneous tissue disorders
Herpes Simplex
|
11.1%
61/551
|
5.1%
14/273
|
|
Skin and subcutaneous tissue disorders
Herpes Zoster
|
3.6%
20/551
|
5.5%
15/273
|
|
Renal and urinary disorders
Urinary Tract Infection
|
23.0%
127/551
|
21.2%
58/273
|
|
Skin and subcutaneous tissue disorders
Skin Carcinoma
|
3.3%
18/551
|
8.8%
24/273
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER