Efficacy and Safety of Enteric-coated Mycophenolate Sodium and Cyclosporine in Combination With and Without Steroids, in Adult Renal Transplant Recipients
Sponsor
Novartis (Industry)
Overall Status
Completed
CT.gov ID
NCT00413920
Collaborator
(none)
222
1
2
Study Details
Study Description
Brief Summary
This study will investigate the efficacy and safety of a steroid avoidance regimen in comparison with steroid treatment in combination with an initially higher dose of enteric-coated mycophenolate sodium (EC-MPS) and cyclosporine microemulsion in de novo renal transplant recipients. Patients will be randomly allocated to receive either EC-MPS or steroids in combination with EC-MPS. Patients of both treatment groups will receive monoclonal antibody induction therapy and a perioperative bolus of steroids and cyclosporine.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
222 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter Randomized Open Label Study to Assess Efficacy and Safety of a Steroid Avoidance Regimen in Comparison to a Treatment With Steroids, in Combination With Enteric-coated Mycophenolate Sodium (EC-MPS) 2.16 g/d for 6 Weeks and Cyclosporine Microemulsion, in de Novo Adult Renal Transplant Recipients
Study Start Date
:
Apr 1, 2007
Actual Primary Completion Date
:
Mar 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Without Steroids Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study. |
Drug: Enteric-coated mycophenolate sodium (EC-MPS)
An initial dose of 1080 mg EC-MPS was administered immediately before transplantation. Then, during the first 6 weeks post-transplantation, EC-MPS was administered at a dose of 1080 mg twice a day 12 hours apart. From week 7 until the end of the study (month 6), EC-MPS was administered at standard dose of 720 mg twice a day.
Other Names:
|
| Active Comparator: With Steroids Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone. |
Drug: Enteric-coated mycophenolate sodium (EC-MPS)
An initial dose of 1080 mg EC-MPS was administered immediately before transplantation. Then, during the first 6 weeks post-transplantation, EC-MPS was administered at a dose of 1080 mg twice a day 12 hours apart. From week 7 until the end of the study (month 6), EC-MPS was administered at standard dose of 720 mg twice a day.
Other Names:
Drug: Prednisone
Oral tablets
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With the Occurrence of Treatment Failures at 6 Months Post-transplantation [6 months post transplantation]
Treatment failures defined as Biopsy Proven Acute Rejection (BPAR), graft loss, death or loss to follow-up. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection. Graft loss: allograft will be presumed to be lost on the day the patient starts dialysis and is not able to subsequently be removed from dialysis.
Secondary Outcome Measures
- The Number of Participants With BPAR, Clinical Acute Rejection (AR) and Treated AR at 6 Months [Month 6]
If a participant experienced several BPAR, only the rejection with highest grade is taken into account. Only events that occurred before study treatment discontinuation are taken into account. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection.
- Number of Participants With Treatment Failure, BPAR, Clinical Acute Rejection (AR) and Treated AR at 3 Months [Month 3]
A treatment failure is a Biopsy Proven Acute Rejection (BPAR), a graft loss, a death, or a loss to follow-up. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection. Graft loss: The allograft will be presumed lost on the day the patient starts dialysis and is not able to subsequently be removed from dialysis.
- Number of Participants With Subclinical Histological Rejections [Month 3]
The number of participants with subclinical histological rejections was determined by renal biopsy screening at 3 months in 125 patients, providing adequate samples for 112 biopsies.
- Number of Participants With Treatment Failure at 3 Months by Graft Recovery Status [Month 3]
The number of participants with treatment failure defined as a Biopsy Proven Acute Rejection (BPAR), a graft loss, a death, or a loss to follow-up at 3 months by graft recovery status. Delayed graft function is defined as the need for dialysis within the first 7 days post-transplantation, excluding the first post-transplantation day. Slow graft function is defined as a serum creatinine value > 250 µmol/L at day 5.
- Number of Participants Requiring Steroids in Non-steroid Treatment Group [Months 3 and 6]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Primary donor kidney transplant
-
Panel reactive antibody (PRA) ≤ 20%
Exclusion Criteria:
-
Multi-organ transplantation including dual kidneys or previous transplant with any other organ different from kidney
-
Non-heart beating donor or kidney from a non-compatible donor
Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | C.H.U. La Milétrie | Poitiers | France |
Sponsors and Collaborators
- Novartis
Investigators
- Study Director: Novartis, Novartis
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00413920
Other Study ID Numbers:
- CERL080AFR05
First Posted:
Dec 20, 2006
Last Update Posted:
Apr 21, 2011
Last Verified:
Apr 1, 2011
Keywords provided by ,
,
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Without Steroids | With Steroids |
|---|---|---|
| Arm/Group Description | Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study. | Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone. |
| Period Title: Overall Study | ||
| STARTED | 112 | 110 |
| COMPLETED | 84 | 82 |
| NOT COMPLETED | 28 | 28 |
Baseline Characteristics
| Arm/Group Title | Without Steroids | With Steroids | Total |
|---|---|---|---|
| Arm/Group Description | Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study. | Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone. | Total of all reporting groups |
| Overall Participants | 112 | 110 | 222 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
51.0
(10.24)
|
50.9
(11.91)
|
51.0
(11.07)
|
| Age, Customized (Number) [Number] | |||
| < 45 years |
33
29.5%
|
25
22.7%
|
58
26.1%
|
| 45-60 years |
56
50%
|
58
52.7%
|
114
51.4%
|
| >= 60 years |
23
20.5%
|
27
24.5%
|
50
22.5%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
36
32.1%
|
40
36.4%
|
76
34.2%
|
| Male |
76
67.9%
|
70
63.6%
|
146
65.8%
|
Outcome Measures
| Title | Number of Participants With the Occurrence of Treatment Failures at 6 Months Post-transplantation |
|---|---|
| Description | Treatment failures defined as Biopsy Proven Acute Rejection (BPAR), graft loss, death or loss to follow-up. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection. Graft loss: allograft will be presumed to be lost on the day the patient starts dialysis and is not able to subsequently be removed from dialysis. |
| Time Frame | 6 months post transplantation |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population |
| Arm/Group Title | Without Steroids | With Steroids |
|---|---|---|
| Arm/Group Description | Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study. | Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone. |
| Measure Participants | 112 | 110 |
| Number [Number of participants] |
20
17.9%
|
16
14.5%
|
| Title | The Number of Participants With BPAR, Clinical Acute Rejection (AR) and Treated AR at 6 Months |
|---|---|
| Description | If a participant experienced several BPAR, only the rejection with highest grade is taken into account. Only events that occurred before study treatment discontinuation are taken into account. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection. |
| Time Frame | Month 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population |
| Arm/Group Title | Without Steroids | With Steroids |
|---|---|---|
| Arm/Group Description | Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study. | Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone. |
| Measure Participants | 112 | 110 |
| Biopsy Proven Acute Rejection |
13
11.6%
|
8
7.3%
|
| Graft Loss |
5
4.5%
|
3
2.7%
|
| Death |
2
1.8%
|
5
4.5%
|
| Loss to Follow-up |
0
0%
|
0
0%
|
| Acute Rejection |
37
33%
|
21
19.1%
|
| Treated Acute Rejection |
36
32.1%
|
19
17.3%
|
| Title | Number of Participants With Treatment Failure, BPAR, Clinical Acute Rejection (AR) and Treated AR at 3 Months |
|---|---|
| Description | A treatment failure is a Biopsy Proven Acute Rejection (BPAR), a graft loss, a death, or a loss to follow-up. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection. Graft loss: The allograft will be presumed lost on the day the patient starts dialysis and is not able to subsequently be removed from dialysis. |
| Time Frame | Month 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population |
| Arm/Group Title | Without Steroids | With Steroids |
|---|---|---|
| Arm/Group Description | Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study. | Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone. |
| Measure Participants | 112 | 110 |
| Treatment Failure |
17
15.2%
|
8
7.3%
|
| Biopsy Proven Acute Rejection |
10
8.9%
|
5
4.5%
|
| Graft Loss |
5
4.5%
|
1
0.9%
|
| Death |
2
1.8%
|
2
1.8%
|
| Loss to Follow-up |
0
0%
|
0
0%
|
| Acute Rejection |
32
28.6%
|
19
17.3%
|
| Treated Acute Rejection |
31
27.7%
|
16
14.5%
|
| Title | Number of Participants With Subclinical Histological Rejections |
|---|---|
| Description | The number of participants with subclinical histological rejections was determined by renal biopsy screening at 3 months in 125 patients, providing adequate samples for 112 biopsies. |
| Time Frame | Month 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population on whom biopsies were performed at 3 months. |
| Arm/Group Title | Without Steroids | With Steroids |
|---|---|---|
| Arm/Group Description | Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study. | Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone. |
| Measure Participants | 59 | 66 |
| Sample quality inadequate |
7
6.3%
|
6
5.5%
|
| Subclinical rejection |
12
10.7%
|
17
15.5%
|
| Borderline lesions |
2
1.8%
|
5
4.5%
|
| BPAR |
10
8.9%
|
12
10.9%
|
| Title | Number of Participants With Treatment Failure at 3 Months by Graft Recovery Status |
|---|---|
| Description | The number of participants with treatment failure defined as a Biopsy Proven Acute Rejection (BPAR), a graft loss, a death, or a loss to follow-up at 3 months by graft recovery status. Delayed graft function is defined as the need for dialysis within the first 7 days post-transplantation, excluding the first post-transplantation day. Slow graft function is defined as a serum creatinine value > 250 µmol/L at day 5. |
| Time Frame | Month 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population. N in the categories is the number of participants from the total population that fit into that category for each arm/group. For example: in the Delayed Graft Function category there were 25 participants in the Without steroid group and 24 participants in the With Steroid Group. |
| Arm/Group Title | Without Steroids | With Steroids |
|---|---|---|
| Arm/Group Description | Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study. | Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone. |
| Measure Participants | 112 | 110 |
| Delayed Graft Function [N= 25,24] |
8
7.1%
|
4
3.6%
|
| Slow Graft Function [N= 36,23] |
6
5.4%
|
1
0.9%
|
| Immediate Graft Function [N= 51,63] |
3
2.7%
|
3
2.7%
|
| Title | Number of Participants Requiring Steroids in Non-steroid Treatment Group |
|---|---|
| Description | |
| Time Frame | Months 3 and 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Without Steroids |
|---|---|
| Arm/Group Description | Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study. |
| Measure Participants | 112 |
| 3 Months |
25
22.3%
|
| 6 Months |
20
17.9%
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Without Steroids | With Steroids | ||
| Arm/Group Description | Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study. | Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone. | ||
All Cause Mortality |
||||
| Without Steroids | With Steroids | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Without Steroids | With Steroids | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 72/112 (64.3%) | 69/110 (62.7%) | ||
| Blood and lymphatic system disorders | ||||
| Agranulocytosis | 0/112 (0%) | 2/110 (1.8%) | ||
| Anaemia | 2/112 (1.8%) | 3/110 (2.7%) | ||
| Febrile neutropenia | 0/112 (0%) | 1/110 (0.9%) | ||
| Haemoglobinaemia | 1/112 (0.9%) | 0/110 (0%) | ||
| Haemolysis | 0/112 (0%) | 1/110 (0.9%) | ||
| Leukocytosis | 1/112 (0.9%) | 0/110 (0%) | ||
| Leukopenia | 1/112 (0.9%) | 4/110 (3.6%) | ||
| Neutropenia | 0/112 (0%) | 4/110 (3.6%) | ||
| Normochromic normocytic anaemia | 1/112 (0.9%) | 0/110 (0%) | ||
| Pancytopenia | 1/112 (0.9%) | 1/110 (0.9%) | ||
| Cardiac disorders | ||||
| Acute coronary syndrome | 1/112 (0.9%) | 0/110 (0%) | ||
| Atrial fibrillation | 1/112 (0.9%) | 0/110 (0%) | ||
| Cardiac arrest | 1/112 (0.9%) | 1/110 (0.9%) | ||
| Coronary artery disease | 0/112 (0%) | 1/110 (0.9%) | ||
| Myocardial infarction | 1/112 (0.9%) | 1/110 (0.9%) | ||
| Pericarditis | 1/112 (0.9%) | 0/110 (0%) | ||
| Sinus bradycardia | 1/112 (0.9%) | 0/110 (0%) | ||
| Endocrine disorders | ||||
| Adrenal insufficiency | 1/112 (0.9%) | 0/110 (0%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain | 2/112 (1.8%) | 5/110 (4.5%) | ||
| Abdominal pain lower | 1/112 (0.9%) | 0/110 (0%) | ||
| Abdominal strangulated hernia | 0/112 (0%) | 2/110 (1.8%) | ||
| Acute abdomen | 0/112 (0%) | 1/110 (0.9%) | ||
| Aphthous stomatitis | 1/112 (0.9%) | 0/110 (0%) | ||
| Colitis | 1/112 (0.9%) | 1/110 (0.9%) | ||
| Diarrhoea | 5/112 (4.5%) | 6/110 (5.5%) | ||
| Gastric ulcer | 0/112 (0%) | 1/110 (0.9%) | ||
| Gastric ulcer haemorrhage | 0/112 (0%) | 1/110 (0.9%) | ||
| Gastroduodenal ulcer | 1/112 (0.9%) | 0/110 (0%) | ||
| Gastrointestinal disorder | 1/112 (0.9%) | 3/110 (2.7%) | ||
| Gastrointestinal haemorrhage | 0/112 (0%) | 1/110 (0.9%) | ||
| Haemorrhoids | 0/112 (0%) | 1/110 (0.9%) | ||
| Ileus | 0/112 (0%) | 1/110 (0.9%) | ||
| Impaired gastric emptying | 1/112 (0.9%) | 0/110 (0%) | ||
| Intestinal ischaemia | 1/112 (0.9%) | 0/110 (0%) | ||
| Intestinal obstruction | 1/112 (0.9%) | 2/110 (1.8%) | ||
| Malabsorption | 1/112 (0.9%) | 0/110 (0%) | ||
| Nausea | 1/112 (0.9%) | 0/110 (0%) | ||
| Oesophagitis | 1/112 (0.9%) | 0/110 (0%) | ||
| Pancreatitis acute | 1/112 (0.9%) | 0/110 (0%) | ||
| Peritonitis | 2/112 (1.8%) | 0/110 (0%) | ||
| Pneumoperitoneum | 1/112 (0.9%) | 0/110 (0%) | ||
| Rectal haemorrhage | 1/112 (0.9%) | 1/110 (0.9%) | ||
| Stomatitis | 0/112 (0%) | 1/110 (0.9%) | ||
| Subileus | 1/112 (0.9%) | 0/110 (0%) | ||
| Vomiting | 4/112 (3.6%) | 4/110 (3.6%) | ||
| General disorders | ||||
| Asthenia | 3/112 (2.7%) | 0/110 (0%) | ||
| Catheter site pain | 1/112 (0.9%) | 0/110 (0%) | ||
| Chills | 5/112 (4.5%) | 3/110 (2.7%) | ||
| Death | 0/112 (0%) | 1/110 (0.9%) | ||
| General physical health deterioration | 0/112 (0%) | 1/110 (0.9%) | ||
| Hyperthermia | 3/112 (2.7%) | 4/110 (3.6%) | ||
| Inflammation | 1/112 (0.9%) | 1/110 (0.9%) | ||
| Oedema peripheral | 2/112 (1.8%) | 1/110 (0.9%) | ||
| Pain | 0/112 (0%) | 1/110 (0.9%) | ||
| Polyp | 0/112 (0%) | 1/110 (0.9%) | ||
| Pyrexia | 10/112 (8.9%) | 10/110 (9.1%) | ||
| Sudden death | 0/112 (0%) | 3/110 (2.7%) | ||
| Hepatobiliary disorders | ||||
| Cholecystitis acute | 1/112 (0.9%) | 0/110 (0%) | ||
| Cholestasis | 1/112 (0.9%) | 0/110 (0%) | ||
| Cytolytic hepatitis | 1/112 (0.9%) | 1/110 (0.9%) | ||
| Immune system disorders | ||||
| Kidney transplant rejection | 1/112 (0.9%) | 1/110 (0.9%) | ||
| Transplant rejection | 1/112 (0.9%) | 0/110 (0%) | ||
| Infections and infestations | ||||
| Acute tonsillitis | 0/112 (0%) | 1/110 (0.9%) | ||
| Bronchitis viral | 1/112 (0.9%) | 0/110 (0%) | ||
| Candidiasis | 0/112 (0%) | 1/110 (0.9%) | ||
| Catheter related infection | 1/112 (0.9%) | 0/110 (0%) | ||
| Cytomegalovirus infection | 6/112 (5.4%) | 10/110 (9.1%) | ||
| Diarrhoea infectious | 1/112 (0.9%) | 0/110 (0%) | ||
| Gastroenteritis | 0/112 (0%) | 1/110 (0.9%) | ||
| Graft infection | 0/112 (0%) | 2/110 (1.8%) | ||
| Herpes zoster | 2/112 (1.8%) | 1/110 (0.9%) | ||
| Infected lymphocele | 0/112 (0%) | 1/110 (0.9%) | ||
| Infection | 0/112 (0%) | 1/110 (0.9%) | ||
| Kidney infection | 0/112 (0%) | 1/110 (0.9%) | ||
| Klebsiella sepsis | 1/112 (0.9%) | 0/110 (0%) | ||
| Mycotic aneurysm | 0/112 (0%) | 1/110 (0.9%) | ||
| Nasopharyngitis | 1/112 (0.9%) | 0/110 (0%) | ||
| Nosocomial infection | 1/112 (0.9%) | 0/110 (0%) | ||
| Orchitis | 0/112 (0%) | 1/110 (0.9%) | ||
| Perinephric abscess | 0/112 (0%) | 1/110 (0.9%) | ||
| Pneumonia | 0/112 (0%) | 1/110 (0.9%) | ||
| Pneumonia cytomegaloviral | 0/112 (0%) | 1/110 (0.9%) | ||
| Pyelonephritis | 5/112 (4.5%) | 9/110 (8.2%) | ||
| Pyelonephritis acute | 3/112 (2.7%) | 1/110 (0.9%) | ||
| Renal cyst infection | 1/112 (0.9%) | 0/110 (0%) | ||
| Sepsis | 2/112 (1.8%) | 3/110 (2.7%) | ||
| Staphylococcal infection | 0/112 (0%) | 1/110 (0.9%) | ||
| Staphylococcal sepsis | 1/112 (0.9%) | 0/110 (0%) | ||
| Urinary tract infection | 4/112 (3.6%) | 4/110 (3.6%) | ||
| Viral infection | 1/112 (0.9%) | 1/110 (0.9%) | ||
| Wound abscess | 0/112 (0%) | 1/110 (0.9%) | ||
| Injury, poisoning and procedural complications | ||||
| Accidental overdose | 0/112 (0%) | 1/110 (0.9%) | ||
| Arterial injury | 0/112 (0%) | 1/110 (0.9%) | ||
| Complications of transplanted kidney | 3/112 (2.7%) | 4/110 (3.6%) | ||
| Drug toxicity | 2/112 (1.8%) | 2/110 (1.8%) | ||
| Graft complication | 1/112 (0.9%) | 2/110 (1.8%) | ||
| Graft dysfunction | 8/112 (7.1%) | 8/110 (7.3%) | ||
| Graft haemorrhage | 0/112 (0%) | 1/110 (0.9%) | ||
| Graft thrombosis | 3/112 (2.7%) | 0/110 (0%) | ||
| Perinephric collection | 1/112 (0.9%) | 0/110 (0%) | ||
| Perirenal haematoma | 1/112 (0.9%) | 2/110 (1.8%) | ||
| Post procedural haematuria | 1/112 (0.9%) | 0/110 (0%) | ||
| Renal injury | 1/112 (0.9%) | 0/110 (0%) | ||
| Spinal compression fracture | 0/112 (0%) | 1/110 (0.9%) | ||
| Therapeutic agent toxicity | 5/112 (4.5%) | 0/110 (0%) | ||
| Urinary anastomotic leak | 0/112 (0%) | 1/110 (0.9%) | ||
| Venous injury | 0/112 (0%) | 1/110 (0.9%) | ||
| Investigations | ||||
| Blood creatinine increased | 10/112 (8.9%) | 8/110 (7.3%) | ||
| Creatinine urine increased | 1/112 (0.9%) | 0/110 (0%) | ||
| Immunosuppressant drug level increased | 1/112 (0.9%) | 0/110 (0%) | ||
| Liver function test abnormal | 1/112 (0.9%) | 0/110 (0%) | ||
| Weight decreased | 2/112 (1.8%) | 1/110 (0.9%) | ||
| Metabolism and nutrition disorders | ||||
| Diabetes mellitus | 0/112 (0%) | 1/110 (0.9%) | ||
| Fluid retention | 0/112 (0%) | 1/110 (0.9%) | ||
| Hypercalcaemia | 1/112 (0.9%) | 0/110 (0%) | ||
| Hypercreatininaemia | 2/112 (1.8%) | 0/110 (0%) | ||
| Hyperglycaemia | 1/112 (0.9%) | 0/110 (0%) | ||
| Hyperkalaemia | 2/112 (1.8%) | 0/110 (0%) | ||
| Hypocalcaemia | 1/112 (0.9%) | 0/110 (0%) | ||
| Hypochloraemia | 0/112 (0%) | 1/110 (0.9%) | ||
| Hypokalaemia | 0/112 (0%) | 1/110 (0.9%) | ||
| Hyponatraemia | 1/112 (0.9%) | 1/110 (0.9%) | ||
| Metabolic alkalosis | 0/112 (0%) | 1/110 (0.9%) | ||
| Overweight | 0/112 (0%) | 1/110 (0.9%) | ||
| Sodium retention | 0/112 (0%) | 1/110 (0.9%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 0/112 (0%) | 2/110 (1.8%) | ||
| Bone pain | 0/112 (0%) | 1/110 (0.9%) | ||
| Flank pain | 1/112 (0.9%) | 0/110 (0%) | ||
| Hypercreatinaemia | 1/112 (0.9%) | 0/110 (0%) | ||
| Musculoskeletal pain | 1/112 (0.9%) | 0/110 (0%) | ||
| Pain in extremity | 1/112 (0.9%) | 0/110 (0%) | ||
| Rhabdomyolysis | 0/112 (0%) | 1/110 (0.9%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Lymphoproliferative disorder | 0/112 (0%) | 1/110 (0.9%) | ||
| Renal cell carcinoma stage unspecified | 1/112 (0.9%) | 0/110 (0%) | ||
| Nervous system disorders | ||||
| Cerebrovascular accident | 0/112 (0%) | 1/110 (0.9%) | ||
| Headache | 1/112 (0.9%) | 0/110 (0%) | ||
| Loss of consciousness | 0/112 (0%) | 1/110 (0.9%) | ||
| Tremor | 0/112 (0%) | 1/110 (0.9%) | ||
| Psychiatric disorders | ||||
| Drug abuse | 1/112 (0.9%) | 0/110 (0%) | ||
| Renal and urinary disorders | ||||
| Anuria | 0/112 (0%) | 1/110 (0.9%) | ||
| Bladder necrosis | 0/112 (0%) | 1/110 (0.9%) | ||
| Detrusor sphincter dyssynergia | 1/112 (0.9%) | 0/110 (0%) | ||
| Haematuria | 1/112 (0.9%) | 1/110 (0.9%) | ||
| Hydronephrosis | 0/112 (0%) | 2/110 (1.8%) | ||
| Nephritis | 1/112 (0.9%) | 0/110 (0%) | ||
| Nephropathy | 1/112 (0.9%) | 0/110 (0%) | ||
| Nephropathy toxic | 1/112 (0.9%) | 1/110 (0.9%) | ||
| Obstructive uropathy | 0/112 (0%) | 1/110 (0.9%) | ||
| Proteinuria | 1/112 (0.9%) | 0/110 (0%) | ||
| Pyelocaliectasis | 1/112 (0.9%) | 1/110 (0.9%) | ||
| Renal aneurysm | 0/112 (0%) | 1/110 (0.9%) | ||
| Renal artery stenosis | 1/112 (0.9%) | 0/110 (0%) | ||
| Renal artery thrombosis | 1/112 (0.9%) | 1/110 (0.9%) | ||
| Renal failure | 2/112 (1.8%) | 2/110 (1.8%) | ||
| Renal failure acute | 12/112 (10.7%) | 10/110 (9.1%) | ||
| Renal impairment | 3/112 (2.7%) | 3/110 (2.7%) | ||
| Renal infarct | 0/112 (0%) | 1/110 (0.9%) | ||
| Renal ischaemia | 0/112 (0%) | 1/110 (0.9%) | ||
| Renal tubular disorder | 1/112 (0.9%) | 0/110 (0%) | ||
| Renal tubular necrosis | 0/112 (0%) | 1/110 (0.9%) | ||
| Renal vein thrombosis | 1/112 (0.9%) | 0/110 (0%) | ||
| Ureteral necrosis | 1/112 (0.9%) | 0/110 (0%) | ||
| Ureteric dilatation | 2/112 (1.8%) | 1/110 (0.9%) | ||
| Ureteric obstruction | 1/112 (0.9%) | 0/110 (0%) | ||
| Ureteric stenosis | 5/112 (4.5%) | 2/110 (1.8%) | ||
| Urinary bladder haemorrhage | 0/112 (0%) | 1/110 (0.9%) | ||
| Urinary retention | 1/112 (0.9%) | 1/110 (0.9%) | ||
| Urinary tract obstruction | 2/112 (1.8%) | 0/110 (0%) | ||
| Urinoma | 1/112 (0.9%) | 2/110 (1.8%) | ||
| Urogenital disorder | 1/112 (0.9%) | 0/110 (0%) | ||
| Reproductive system and breast disorders | ||||
| Prostatitis | 1/112 (0.9%) | 1/110 (0.9%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Acute pulmonary oedema | 2/112 (1.8%) | 1/110 (0.9%) | ||
| Acute respiratory distress syndrome | 1/112 (0.9%) | 0/110 (0%) | ||
| Aspiration | 1/112 (0.9%) | 0/110 (0%) | ||
| Cough | 0/112 (0%) | 2/110 (1.8%) | ||
| Dyspnoea | 1/112 (0.9%) | 1/110 (0.9%) | ||
| Hypoxia | 0/112 (0%) | 1/110 (0.9%) | ||
| Interstitial lung disease | 0/112 (0%) | 1/110 (0.9%) | ||
| Lung disorder | 1/112 (0.9%) | 1/110 (0.9%) | ||
| Pneumothorax | 1/112 (0.9%) | 0/110 (0%) | ||
| Pulmonary embolism | 1/112 (0.9%) | 1/110 (0.9%) | ||
| Pulmonary oedema | 1/112 (0.9%) | 0/110 (0%) | ||
| Respiratory arrest | 1/112 (0.9%) | 0/110 (0%) | ||
| Respiratory distress | 1/112 (0.9%) | 0/110 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Hyperhidrosis | 0/112 (0%) | 1/110 (0.9%) | ||
| Skin necrosis | 1/112 (0.9%) | 0/110 (0%) | ||
| Surgical and medical procedures | ||||
| Catheter removal | 0/112 (0%) | 1/110 (0.9%) | ||
| Nephrectomy | 1/112 (0.9%) | 0/110 (0%) | ||
| Nephrostomy tube removal | 0/112 (0%) | 1/110 (0.9%) | ||
| Transurethral prostatectomy | 0/112 (0%) | 1/110 (0.9%) | ||
| Venous ligation | 1/112 (0.9%) | 0/110 (0%) | ||
| Vascular disorders | ||||
| Angiosclerosis | 1/112 (0.9%) | 0/110 (0%) | ||
| Arterial thrombosis | 1/112 (0.9%) | 0/110 (0%) | ||
| Axillary vein thrombosis | 1/112 (0.9%) | 0/110 (0%) | ||
| Circulatory collapse | 1/112 (0.9%) | 0/110 (0%) | ||
| Deep vein thrombosis | 1/112 (0.9%) | 0/110 (0%) | ||
| Extrinsic vascular compression | 1/112 (0.9%) | 0/110 (0%) | ||
| Haematoma | 3/112 (2.7%) | 2/110 (1.8%) | ||
| Haemorrhage | 0/112 (0%) | 1/110 (0.9%) | ||
| Hypertension | 0/112 (0%) | 1/110 (0.9%) | ||
| Hypotension | 0/112 (0%) | 1/110 (0.9%) | ||
| Lymphocele | 3/112 (2.7%) | 5/110 (4.5%) | ||
| Orthostatic hypotension | 1/112 (0.9%) | 0/110 (0%) | ||
| Venous thrombosis | 1/112 (0.9%) | 0/110 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Without Steroids | With Steroids | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 104/112 (92.9%) | 107/110 (97.3%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 60/112 (53.6%) | 56/110 (50.9%) | ||
| Leukopenia | 21/112 (18.8%) | 12/110 (10.9%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain | 12/112 (10.7%) | 6/110 (5.5%) | ||
| Aphthous stomatitis | 4/112 (3.6%) | 6/110 (5.5%) | ||
| Constipation | 17/112 (15.2%) | 17/110 (15.5%) | ||
| Diarrhoea | 15/112 (13.4%) | 16/110 (14.5%) | ||
| Gastrointestinal disorder | 2/112 (1.8%) | 7/110 (6.4%) | ||
| Gingival hypertrophy | 8/112 (7.1%) | 8/110 (7.3%) | ||
| General disorders | ||||
| Oedema peripheral | 27/112 (24.1%) | 27/110 (24.5%) | ||
| Pain | 15/112 (13.4%) | 13/110 (11.8%) | ||
| Hepatobiliary disorders | ||||
| Cytolytic hepatitis | 1/112 (0.9%) | 8/110 (7.3%) | ||
| Infections and infestations | ||||
| Bronchitis | 5/112 (4.5%) | 8/110 (7.3%) | ||
| Cytomegalovirus infection | 9/112 (8%) | 16/110 (14.5%) | ||
| Urinary tract infection | 34/112 (30.4%) | 39/110 (35.5%) | ||
| Injury, poisoning and procedural complications | ||||
| Complications of transplanted kidney | 8/112 (7.1%) | 9/110 (8.2%) | ||
| Graft dysfunction | 16/112 (14.3%) | 18/110 (16.4%) | ||
| Investigations | ||||
| Blood phosphorus decreased | 4/112 (3.6%) | 6/110 (5.5%) | ||
| Metabolism and nutrition disorders | ||||
| Acidosis | 8/112 (7.1%) | 4/110 (3.6%) | ||
| Diabetes mellitus | 10/112 (8.9%) | 11/110 (10%) | ||
| Dyslipidaemia | 10/112 (8.9%) | 21/110 (19.1%) | ||
| Fluid retention | 9/112 (8%) | 7/110 (6.4%) | ||
| Hyperglycaemia | 30/112 (26.8%) | 31/110 (28.2%) | ||
| Hyperkalaemia | 19/112 (17%) | 9/110 (8.2%) | ||
| Hypocalcaemia | 6/112 (5.4%) | 5/110 (4.5%) | ||
| Hypokalaemia | 11/112 (9.8%) | 17/110 (15.5%) | ||
| Nervous system disorders | ||||
| Tremor | 10/112 (8.9%) | 7/110 (6.4%) | ||
| Psychiatric disorders | ||||
| Insomnia | 20/112 (17.9%) | 18/110 (16.4%) | ||
| Renal and urinary disorders | ||||
| Haematuria | 8/112 (7.1%) | 7/110 (6.4%) | ||
| Proteinuria | 6/112 (5.4%) | 9/110 (8.2%) | ||
| Vascular disorders | ||||
| Hypertension | 20/112 (17.9%) | 17/110 (15.5%) | ||
| Lymphocele | 2/112 (1.8%) | 7/110 (6.4%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Novartis Pharmaceuticals |
| Phone | 862-778-8300 |
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00413920
Other Study ID Numbers:
- CERL080AFR05
First Posted:
Dec 20, 2006
Last Update Posted:
Apr 21, 2011
Last Verified:
Apr 1, 2011