Trial Outcomes & Findings for Efficacy and Safety of Early Versus Delayed Administration of Everolimus in de Novo Renal Transplant Patients (NCT NCT00154297)
NCT ID: NCT00154297
Last Updated: 2011-04-04
Results Overview
"In Failure", is at least one of these events occurred within the first 3 months: delayed graft function(DGF), (need for dialysis within the first 7 days,minus day one,post-transplantation); Biopsy proven acute rejection (BPAR), Graft loss, (allograft was presumed lost on the day the patient started and not removable from dialysis). Death; Loss to follow-up; Wound healing disorder(Any wound related to the kidney transplantation being opened beyond 3 weeks, or infected, or drained fluid or herniated was considered not healed).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
139 participants
Primary outcome timeframe
Month 3
Results posted on
2011-04-04
Participant Flow
Participant milestones
| Measure |
Immediate Everolimus
Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
|
Delayed Everolimus
Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
74
|
|
Overall Study
COMPLETED
|
57
|
67
|
|
Overall Study
NOT COMPLETED
|
8
|
7
|
Reasons for withdrawal
| Measure |
Immediate Everolimus
Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
|
Delayed Everolimus
Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
|
|---|---|---|
|
Overall Study
Death
|
5
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
5
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
Baseline Characteristics
Efficacy and Safety of Early Versus Delayed Administration of Everolimus in de Novo Renal Transplant Patients
Baseline characteristics by cohort
| Measure |
Immediate Everolimus
n=65 Participants
Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
|
Delayed Everolimus
n=74 Participants
Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
57.3 years
STANDARD_DEVIATION 10.46 • n=5 Participants
|
58.4 years
STANDARD_DEVIATION 9.86 • n=7 Participants
|
57.9 years
STANDARD_DEVIATION 10.13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 3Population: Intention to treat (ITT) population.
"In Failure", is at least one of these events occurred within the first 3 months: delayed graft function(DGF), (need for dialysis within the first 7 days,minus day one,post-transplantation); Biopsy proven acute rejection (BPAR), Graft loss, (allograft was presumed lost on the day the patient started and not removable from dialysis). Death; Loss to follow-up; Wound healing disorder(Any wound related to the kidney transplantation being opened beyond 3 weeks, or infected, or drained fluid or herniated was considered not healed).
Outcome measures
| Measure |
Immediate Everolimus
n=65 Participants
Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
|
Delayed Everolimus
n=74 Participants
Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
|
|---|---|---|
|
Number of Participants Considered in Failure for the Primary Failure Endpoint at 3 Months
Dialysis within first 7 days
|
16 Participants
|
18 Participants
|
|
Number of Participants Considered in Failure for the Primary Failure Endpoint at 3 Months
--Death
|
4 Participants
|
2 Participants
|
|
Number of Participants Considered in Failure for the Primary Failure Endpoint at 3 Months
Loss to follow-up for the primary failure endpoint
|
0 Participants
|
3 Participants
|
|
Number of Participants Considered in Failure for the Primary Failure Endpoint at 3 Months
Failure at month 3 - Total
|
36 Participants
|
47 Participants
|
|
Number of Participants Considered in Failure for the Primary Failure Endpoint at 3 Months
Efficacy failure (Total)
|
14 Participants
|
15 Participants
|
|
Number of Participants Considered in Failure for the Primary Failure Endpoint at 3 Months
--BPAR
|
7 Participants
|
7 Participants
|
|
Number of Participants Considered in Failure for the Primary Failure Endpoint at 3 Months
--Graft Loss
|
5 Participants
|
3 Participants
|
|
Number of Participants Considered in Failure for the Primary Failure Endpoint at 3 Months
--Lost to follow-up (composite efficacy endpoint)
|
0 Participants
|
4 Participants
|
|
Number of Participants Considered in Failure for the Primary Failure Endpoint at 3 Months
Wound healing disorder
|
24 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: at 6 Month post-transplantationPopulation: Intention to treat (ITT) population.
The primary efficacy variable was the "primary failure endpoint" at 6 months defined as the occurrence of one or more of the following events within the first 6 months: * delayed graft function (DGF), defined as the need for dialysis within the first 7 days post-transplantation excluding the first day post-transplantation * efficacy failure (biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up) * wound healing disorder related to initial transplant surgery
Outcome measures
| Measure |
Immediate Everolimus
n=65 Participants
Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
|
Delayed Everolimus
n=74 Participants
Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
|
|---|---|---|
|
Number of Participants Considered in Failure for the Primary Failure Endpoint at 6 Months Post-transplantation.
--Graft Loss
|
5 Participants
|
4 Participants
|
|
Number of Participants Considered in Failure for the Primary Failure Endpoint at 6 Months Post-transplantation.
--Death
|
4 Participants
|
2 Participants
|
|
Number of Participants Considered in Failure for the Primary Failure Endpoint at 6 Months Post-transplantation.
Failure at month 6 - Total
|
39 Participants
|
48 Participants
|
|
Number of Participants Considered in Failure for the Primary Failure Endpoint at 6 Months Post-transplantation.
Dialysis within first 7 days
|
16 Participants
|
18 Participants
|
|
Number of Participants Considered in Failure for the Primary Failure Endpoint at 6 Months Post-transplantation.
Efficacy failure (Total)
|
17 Participants
|
22 Participants
|
|
Number of Participants Considered in Failure for the Primary Failure Endpoint at 6 Months Post-transplantation.
--BPAR
|
10 Participants
|
13 Participants
|
|
Number of Participants Considered in Failure for the Primary Failure Endpoint at 6 Months Post-transplantation.
--Lost to follow-up (composite efficacy endpoint)
|
0 Participants
|
4 Participants
|
|
Number of Participants Considered in Failure for the Primary Failure Endpoint at 6 Months Post-transplantation.
Wound healing disorder
|
25 Participants
|
28 Participants
|
|
Number of Participants Considered in Failure for the Primary Failure Endpoint at 6 Months Post-transplantation.
Loss to follow-up for the primary failure endpoint
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: at 12 Month post-transplantationPopulation: Intention to treat (ITT) population.
The primary efficacy variable was the "primary failure endpoint" at 12 months defined as the occurrence of one or more of the following events within the first 12 months: * delayed graft function (DGF), defined as the need for dialysis within the first 7 days post-transplantation excluding the first day post-transplantation * efficacy failure (biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up) * wound healing disorder related to initial transplant surgery
Outcome measures
| Measure |
Immediate Everolimus
n=65 Participants
Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
|
Delayed Everolimus
n=74 Participants
Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
|
|---|---|---|
|
Number of Participants Considered in Failure for the Primary Failure Endpoint at 12 Months Post-transplantation.
--Graft Loss
|
6 Participants
|
5 Participants
|
|
Number of Participants Considered in Failure for the Primary Failure Endpoint at 12 Months Post-transplantation.
--Death
|
5 Participants
|
2 Participants
|
|
Number of Participants Considered in Failure for the Primary Failure Endpoint at 12 Months Post-transplantation.
Wound healing disorder
|
26 Participants
|
28 Participants
|
|
Number of Participants Considered in Failure for the Primary Failure Endpoint at 12 Months Post-transplantation.
Failure at month 12 - Total
|
42 Participants
|
49 Participants
|
|
Number of Participants Considered in Failure for the Primary Failure Endpoint at 12 Months Post-transplantation.
Dialysis within first 7 days
|
16 Participants
|
18 Participants
|
|
Number of Participants Considered in Failure for the Primary Failure Endpoint at 12 Months Post-transplantation.
Efficacy failure (Total)
|
22 Participants
|
25 Participants
|
|
Number of Participants Considered in Failure for the Primary Failure Endpoint at 12 Months Post-transplantation.
--BPAR
|
13 Participants
|
15 Participants
|
|
Number of Participants Considered in Failure for the Primary Failure Endpoint at 12 Months Post-transplantation.
--Lost to follow-up (composite efficacy endpoint)
|
0 Participants
|
5 Participants
|
|
Number of Participants Considered in Failure for the Primary Failure Endpoint at 12 Months Post-transplantation.
Loss to follow-up for the primary failure endpoint
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Month 12Population: Intention to treat (ITT) population.
The number of patients who underwent any dialysis within the 12-month treatment period.
Outcome measures
| Measure |
Immediate Everolimus
n=65 Participants
Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
|
Delayed Everolimus
n=74 Participants
Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
|
|---|---|---|
|
Number of Participants Who Underwent Any Dialysis Within the 12-month Treatment Period
|
16 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The number of patients analyzed includes those with any dialysis in the 12 month period
The mean duration in days of any dialysis session that occurred within the 12 month treatment period.
Outcome measures
| Measure |
Immediate Everolimus
n=16 Participants
Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
|
Delayed Everolimus
n=24 Participants
Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
|
|---|---|---|
|
Duration of Dialysis
|
11.9 Days
Standard Deviation 7.01
|
7.8 Days
Standard Deviation 7.42
|
SECONDARY outcome
Timeframe: Month 12Population: Intention to treat (ITT) population.
A wound was considered healed if all the suture material and staples were removed and the wound was intact by 3 weeks. Any wound opened beyond this point, infected, drained fluid or herniated was considered not healed.
Outcome measures
| Measure |
Immediate Everolimus
n=65 Participants
Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
|
Delayed Everolimus
n=74 Participants
Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
|
|---|---|---|
|
Number of Participants With Any Wound Healing Disorder During the 12-month Treatment Period
Any wound healing disorder -Total
|
28 Participants
|
32 Participants
|
|
Number of Participants With Any Wound Healing Disorder During the 12-month Treatment Period
Wound healing disorder related to transplant
|
26 Participants
|
28 Participants
|
|
Number of Participants With Any Wound Healing Disorder During the 12-month Treatment Period
Wound healing disorder unrelated to transplant
|
2 Participants
|
6 Participants
|
Adverse Events
Immediate Everolimus
Serious events: 45 serious events
Other events: 64 other events
Deaths: 0 deaths
Delayed Everolimus
Serious events: 57 serious events
Other events: 70 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Immediate Everolimus
n=65 participants at risk
Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
|
Delayed Everolimus
n=74 participants at risk
Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/65 • Month 12
|
2.7%
2/74 • Month 12
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.1%
2/65 • Month 12
|
2.7%
2/74 • Month 12
|
|
Cardiac disorders
Acute coronary syndrome
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Cardiac disorders
Cardiac arrest
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Cardiac disorders
Cardiac failure
|
1.5%
1/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Cardiac disorders
Myocardial infarction
|
1.5%
1/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Eye disorders
Amaurosis
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Eye disorders
Cataract
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Eye disorders
Retinal artery thrombosis
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/65 • Month 12
|
2.7%
2/74 • Month 12
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Gastrointestinal disorders
Colitis
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Gastrointestinal disorders
Diarrhoea
|
3.1%
2/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Gastrointestinal disorders
Hernial eventration
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Gastrointestinal disorders
Nausea
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Gastrointestinal disorders
Tongue oedema
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
2/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
General disorders
Asthenia
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
General disorders
Chills
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
General disorders
Hyperthermia
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
General disorders
Implant site haematoma
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
General disorders
Oedema
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
General disorders
Oedema peripheral
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
General disorders
Pyrexia
|
1.5%
1/65 • Month 12
|
6.8%
5/74 • Month 12
|
|
General disorders
Sudden death
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Hepatobiliary disorders
Cytolytic hepatitis
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Immune system disorders
Transplant rejection
|
4.6%
3/65 • Month 12
|
8.1%
6/74 • Month 12
|
|
Infections and infestations
Abscess
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Infections and infestations
Arthritis bacterial
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Infections and infestations
Aspergillosis
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Infections and infestations
Bronchitis
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Infections and infestations
Catheter sepsis
|
1.5%
1/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Infections and infestations
Cerebral aspergillosis
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Infections and infestations
Cytomegalovirus infection
|
1.5%
1/65 • Month 12
|
2.7%
2/74 • Month 12
|
|
Infections and infestations
Encephalitic infection
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Infections and infestations
Endocarditis
|
1.5%
1/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Infections and infestations
Genital infection
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Infections and infestations
Infected lymphocele
|
3.1%
2/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Infections and infestations
Kidney infection
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Infections and infestations
Lung infection
|
4.6%
3/65 • Month 12
|
2.7%
2/74 • Month 12
|
|
Infections and infestations
Lymph node tuberculosis
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Infections and infestations
Peritoneal infection
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Infections and infestations
Pneumonia
|
1.5%
1/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Infections and infestations
Prostate infection
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Infections and infestations
Pseudomembranous colitis
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Infections and infestations
Pyelonephritis
|
9.2%
6/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Infections and infestations
Pyelonephritis acute
|
6.2%
4/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Infections and infestations
Sepsis
|
1.5%
1/65 • Month 12
|
6.8%
5/74 • Month 12
|
|
Infections and infestations
Septic shock
|
4.6%
3/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Infections and infestations
Urinary tract infection
|
7.7%
5/65 • Month 12
|
9.5%
7/74 • Month 12
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
7.7%
5/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
1.5%
1/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Injury, poisoning and procedural complications
Fall
|
1.5%
1/65 • Month 12
|
2.7%
2/74 • Month 12
|
|
Injury, poisoning and procedural complications
Foot fracture
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Injury, poisoning and procedural complications
Graft loss
|
3.1%
2/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Injury, poisoning and procedural complications
Graft thrombosis
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
3.1%
2/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Injury, poisoning and procedural complications
Multiple drug overdose
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Injury, poisoning and procedural complications
Overdose
|
1.5%
1/65 • Month 12
|
2.7%
2/74 • Month 12
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
3.1%
2/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Investigations
Blood creatine increased
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Investigations
Blood creatinine increased
|
9.2%
6/65 • Month 12
|
6.8%
5/74 • Month 12
|
|
Investigations
C-reactive protein increased
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Investigations
Red blood cell count decreased
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Investigations
Weight decreased
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Metabolism and nutrition disorders
Anorexia
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/65 • Month 12
|
2.7%
2/74 • Month 12
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/65 • Month 12
|
2.7%
2/74 • Month 12
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
1.5%
1/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Nervous system disorders
Headache
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Nervous system disorders
Syncope
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Psychiatric disorders
Delirium
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Renal and urinary disorders
Anuria
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Renal and urinary disorders
Bladder disorder
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Renal and urinary disorders
Extravasation of urine
|
1.5%
1/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Renal and urinary disorders
Haematuria
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.00%
0/65 • Month 12
|
2.7%
2/74 • Month 12
|
|
Renal and urinary disorders
Nephrotic syndrome
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Renal and urinary disorders
Obstructive uropathy
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/65 • Month 12
|
2.7%
2/74 • Month 12
|
|
Renal and urinary disorders
Pyelocaliectasis
|
1.5%
1/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Renal and urinary disorders
Renal aneurysm
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Renal and urinary disorders
Renal artery stenosis
|
1.5%
1/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Renal and urinary disorders
Renal failure
|
1.5%
1/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Renal and urinary disorders
Renal failure acute
|
6.2%
4/65 • Month 12
|
9.5%
7/74 • Month 12
|
|
Renal and urinary disorders
Renal impairment
|
6.2%
4/65 • Month 12
|
4.1%
3/74 • Month 12
|
|
Renal and urinary disorders
Renal tubular disorder
|
0.00%
0/65 • Month 12
|
2.7%
2/74 • Month 12
|
|
Renal and urinary disorders
Renal tubular necrosis
|
3.1%
2/65 • Month 12
|
2.7%
2/74 • Month 12
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/65 • Month 12
|
2.7%
2/74 • Month 12
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/65 • Month 12
|
2.7%
2/74 • Month 12
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.5%
1/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/65 • Month 12
|
2.7%
2/74 • Month 12
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.5%
1/65 • Month 12
|
2.7%
2/74 • Month 12
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Vascular disorders
Arterial haemorrhage
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Vascular disorders
Arterial thrombosis
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Vascular disorders
Haematoma
|
1.5%
1/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Vascular disorders
Hypertension
|
3.1%
2/65 • Month 12
|
5.4%
4/74 • Month 12
|
|
Vascular disorders
Lymphocele
|
6.2%
4/65 • Month 12
|
4.1%
3/74 • Month 12
|
|
Vascular disorders
Phlebitis
|
1.5%
1/65 • Month 12
|
5.4%
4/74 • Month 12
|
|
Vascular disorders
Superior vena caval stenosis
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Vascular disorders
Vena cava thrombosis
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
|
Vascular disorders
Venous thrombosis
|
1.5%
1/65 • Month 12
|
0.00%
0/74 • Month 12
|
Other adverse events
| Measure |
Immediate Everolimus
n=65 participants at risk
Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
|
Delayed Everolimus
n=74 participants at risk
Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
43.1%
28/65 • Month 12
|
44.6%
33/74 • Month 12
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.6%
3/65 • Month 12
|
5.4%
4/74 • Month 12
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.8%
7/65 • Month 12
|
5.4%
4/74 • Month 12
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
10.8%
7/65 • Month 12
|
6.8%
5/74 • Month 12
|
|
Gastrointestinal disorders
Constipation
|
18.5%
12/65 • Month 12
|
18.9%
14/74 • Month 12
|
|
Gastrointestinal disorders
Diarrhoea
|
10.8%
7/65 • Month 12
|
5.4%
4/74 • Month 12
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/65 • Month 12
|
5.4%
4/74 • Month 12
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
5/65 • Month 12
|
5.4%
4/74 • Month 12
|
|
General disorders
Oedema peripheral
|
40.0%
26/65 • Month 12
|
55.4%
41/74 • Month 12
|
|
General disorders
Pyrexia
|
6.2%
4/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Infections and infestations
Bronchitis
|
6.2%
4/65 • Month 12
|
4.1%
3/74 • Month 12
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/65 • Month 12
|
5.4%
4/74 • Month 12
|
|
Infections and infestations
Urinary tract infection
|
33.8%
22/65 • Month 12
|
33.8%
25/74 • Month 12
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
23.1%
15/65 • Month 12
|
25.7%
19/74 • Month 12
|
|
Metabolism and nutrition disorders
Acidosis
|
7.7%
5/65 • Month 12
|
6.8%
5/74 • Month 12
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
9.2%
6/65 • Month 12
|
12.2%
9/74 • Month 12
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
18.5%
12/65 • Month 12
|
20.3%
15/74 • Month 12
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
9.2%
6/65 • Month 12
|
12.2%
9/74 • Month 12
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.7%
5/65 • Month 12
|
6.8%
5/74 • Month 12
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
9.2%
6/65 • Month 12
|
5.4%
4/74 • Month 12
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
9.2%
6/65 • Month 12
|
4.1%
3/74 • Month 12
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
7.7%
5/65 • Month 12
|
5.4%
4/74 • Month 12
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
9.2%
6/65 • Month 12
|
5.4%
4/74 • Month 12
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.7%
5/65 • Month 12
|
17.6%
13/74 • Month 12
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
9.2%
6/65 • Month 12
|
9.5%
7/74 • Month 12
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
1/65 • Month 12
|
6.8%
5/74 • Month 12
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
6.2%
4/65 • Month 12
|
5.4%
4/74 • Month 12
|
|
Nervous system disorders
Tremor
|
7.7%
5/65 • Month 12
|
10.8%
8/74 • Month 12
|
|
Psychiatric disorders
Anxiety
|
6.2%
4/65 • Month 12
|
1.4%
1/74 • Month 12
|
|
Psychiatric disorders
Insomnia
|
4.6%
3/65 • Month 12
|
8.1%
6/74 • Month 12
|
|
Renal and urinary disorders
Bladder spasm
|
1.5%
1/65 • Month 12
|
5.4%
4/74 • Month 12
|
|
Renal and urinary disorders
Haematuria
|
3.1%
2/65 • Month 12
|
8.1%
6/74 • Month 12
|
|
Renal and urinary disorders
Proteinuria
|
12.3%
8/65 • Month 12
|
6.8%
5/74 • Month 12
|
|
Renal and urinary disorders
Renal impairment
|
9.2%
6/65 • Month 12
|
6.8%
5/74 • Month 12
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
4/65 • Month 12
|
4.1%
3/74 • Month 12
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.1%
2/65 • Month 12
|
6.8%
5/74 • Month 12
|
|
Vascular disorders
Haematoma
|
9.2%
6/65 • Month 12
|
14.9%
11/74 • Month 12
|
|
Vascular disorders
Hypertension
|
23.1%
15/65 • Month 12
|
23.0%
17/74 • Month 12
|
|
Vascular disorders
Lymphocele
|
13.8%
9/65 • Month 12
|
10.8%
8/74 • Month 12
|
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