Trial Outcomes & Findings for Comparison of CNI-based Regimen Versus CNI-free Regimen in Kidney Transplant Recipients. (NCT NCT00332839)
NCT ID: NCT00332839
Last Updated: 2014-08-28
Results Overview
The analysis for this outcome measure was not perfomed because the analyses could not be powered for efficacy due to low recruitment.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
93 participants
Primary outcome timeframe
12 months
Results posted on
2014-08-28
Participant Flow
Renal transplant recipients at least 6 months post transplantation were randomized to the CNI group or Certican group. Post 12 months, participants entered a follow-up phase for an additional 48 months. Thirty-three participants in the CNI group and 34 participants in the Certican group had a month 60 follow-up status.
Participant milestones
| Measure |
Calcineurin Inhibitor (CNI) Group
Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
|
Certican Group
Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
|
|---|---|---|
|
Core (Months 0 - 12)
STARTED
|
47
|
46
|
|
Core (Months 0 - 12)
Safety Set
|
47
|
46
|
|
Core (Months 0 - 12)
COMPLETED
|
37
|
28
|
|
Core (Months 0 - 12)
NOT COMPLETED
|
10
|
18
|
|
Follow-up (Months 12 - 60)
STARTED
|
33
|
34
|
|
Follow-up (Months 12 - 60)
COMPLETED
|
29
|
31
|
|
Follow-up (Months 12 - 60)
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Calcineurin Inhibitor (CNI) Group
Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
|
Certican Group
Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
|
|---|---|---|
|
Core (Months 0 - 12)
Administrative problems
|
1
|
1
|
|
Core (Months 0 - 12)
Withdrawal by Subject
|
3
|
1
|
|
Core (Months 0 - 12)
Protocol deviation
|
1
|
1
|
|
Core (Months 0 - 12)
Adverse Event
|
5
|
15
|
|
Follow-up (Months 12 - 60)
Withdrawal by Subject
|
1
|
1
|
|
Follow-up (Months 12 - 60)
Lost to Follow-up
|
2
|
1
|
|
Follow-up (Months 12 - 60)
Death
|
1
|
1
|
Baseline Characteristics
Comparison of CNI-based Regimen Versus CNI-free Regimen in Kidney Transplant Recipients.
Baseline characteristics by cohort
| Measure |
Calcineurin Inhibitor (CNI) Group
n=47 Participants
Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
|
Certican Group
n=46 Participants
Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.8 Years
STANDARD_DEVIATION 11.1 • n=93 Participants
|
51.0 Years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
50.4 Years
STANDARD_DEVIATION 10.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
64 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 monthsThe analysis for this outcome measure was not perfomed because the analyses could not be powered for efficacy due to low recruitment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsThe analysis for this outcome measure was not perfomed because the analyses could not be powered for efficacy due to low recruitment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsThe analysis for this outcome measure was not perfomed because the analyses could not be powered for efficacy due to low recruitment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 monthsThe analysis for this outcome measure was not perfomed because the analyses could not be powered for efficacy due to low recruitment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: The safety set, which included all randomized participants, comprised the analysis population.
Participants were monitored for adverse events, serious adverse events and deaths thorughout the prospective and follow-up phases of the study.
Outcome measures
| Measure |
Calcineurin Inhibitor (CNI) Group
n=47 Participants
Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
|
Certican Group
n=46 Participants
Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
|
|---|---|---|
|
Number of Participants Who Experienced Adverse Events and Death
Adverse events (serious and non-serious)
|
44 Participants
|
44 Participants
|
|
Number of Participants Who Experienced Adverse Events and Death
Serious adverse events
|
11 Participants
|
12 Participants
|
|
Number of Participants Who Experienced Adverse Events and Death
Deaths
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, 12 monthsThe analysis for this outcome measure was not perfomed because the analyses could not be powered for efficacy due to low recruitment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 monthsThe analysis for this outcome measure was not perfomed because the analyses could not be powered for efficacy due to low recruitment.
Outcome measures
Outcome data not reported
Adverse Events
Calcineurin Inhibitor (CNI) Group
Serious events: 11 serious events
Other events: 31 other events
Deaths: 0 deaths
Certican Group
Serious events: 12 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Calcineurin Inhibitor (CNI) Group
n=47 participants at risk
Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
|
Certican Group
n=46 participants at risk
Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.1%
1/47
|
0.00%
0/46
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
2.1%
1/47
|
0.00%
0/46
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.1%
1/47
|
0.00%
0/46
|
|
Cardiac disorders
Atrial fibrillation
|
2.1%
1/47
|
0.00%
0/46
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/47
|
2.2%
1/46
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/47
|
2.2%
1/46
|
|
Gastrointestinal disorders
Anal haemorrhage
|
2.1%
1/47
|
0.00%
0/46
|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
2/47
|
2.2%
1/46
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/47
|
2.2%
1/46
|
|
Gastrointestinal disorders
Enterocolitis
|
2.1%
1/47
|
0.00%
0/46
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/47
|
2.2%
1/46
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
2.1%
1/47
|
0.00%
0/46
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/47
|
2.2%
1/46
|
|
General disorders
Multi-organ failure
|
0.00%
0/47
|
2.2%
1/46
|
|
General disorders
Nodule
|
0.00%
0/47
|
2.2%
1/46
|
|
General disorders
Pyrexia
|
0.00%
0/47
|
2.2%
1/46
|
|
Infections and infestations
Abscess
|
2.1%
1/47
|
0.00%
0/46
|
|
Infections and infestations
Cystitis klebsiella
|
0.00%
0/47
|
2.2%
1/46
|
|
Infections and infestations
Cytomegalovirus colitis
|
2.1%
1/47
|
2.2%
1/46
|
|
Infections and infestations
Cytomegalovirus gastroenteritis
|
2.1%
1/47
|
0.00%
0/46
|
|
Infections and infestations
Erysipelas
|
0.00%
0/47
|
2.2%
1/46
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/47
|
2.2%
1/46
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/47
|
2.2%
1/46
|
|
Infections and infestations
Infection
|
2.1%
1/47
|
0.00%
0/46
|
|
Infections and infestations
Pneumonia
|
0.00%
0/47
|
2.2%
1/46
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/47
|
2.2%
1/46
|
|
Infections and infestations
Proteus infection
|
0.00%
0/47
|
2.2%
1/46
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/47
|
2.2%
1/46
|
|
Infections and infestations
Sepsis
|
0.00%
0/47
|
2.2%
1/46
|
|
Infections and infestations
Urinary tract infection
|
2.1%
1/47
|
6.5%
3/46
|
|
Infections and infestations
Wound infection
|
0.00%
0/47
|
2.2%
1/46
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/47
|
2.2%
1/46
|
|
Injury, poisoning and procedural complications
Graft dysfunction
|
2.1%
1/47
|
0.00%
0/46
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
2.1%
1/47
|
0.00%
0/46
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/47
|
2.2%
1/46
|
|
Injury, poisoning and procedural complications
Transplant failure
|
2.1%
1/47
|
0.00%
0/46
|
|
Investigations
Blood creatinine increased
|
4.3%
2/47
|
0.00%
0/46
|
|
Investigations
Blood human chorionic gonadotropin increased
|
2.1%
1/47
|
0.00%
0/46
|
|
Investigations
Weight decreased
|
0.00%
0/47
|
2.2%
1/46
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/47
|
2.2%
1/46
|
|
Metabolism and nutrition disorders
Dehydration
|
2.1%
1/47
|
0.00%
0/46
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
2.1%
1/47
|
0.00%
0/46
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
2.1%
1/47
|
0.00%
0/46
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
2.1%
1/47
|
0.00%
0/46
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/47
|
2.2%
1/46
|
|
Nervous system disorders
Migraine without aura
|
2.1%
1/47
|
0.00%
0/46
|
|
Renal and urinary disorders
Albuminuria
|
0.00%
0/47
|
2.2%
1/46
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/47
|
2.2%
1/46
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/47
|
2.2%
1/46
|
|
Reproductive system and breast disorders
Testicular disorder
|
0.00%
0/47
|
2.2%
1/46
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/47
|
2.2%
1/46
|
|
Vascular disorders
Hypertensive crisis
|
2.1%
1/47
|
0.00%
0/46
|
Other adverse events
| Measure |
Calcineurin Inhibitor (CNI) Group
n=47 participants at risk
Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
|
Certican Group
n=46 participants at risk
Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.4%
3/47
|
17.4%
8/46
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.3%
2/47
|
13.0%
6/46
|
|
Gastrointestinal disorders
Abdominal pain
|
10.6%
5/47
|
2.2%
1/46
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/47
|
26.1%
12/46
|
|
Gastrointestinal disorders
Diarrhoea
|
21.3%
10/47
|
15.2%
7/46
|
|
General disorders
Oedema peripheral
|
6.4%
3/47
|
23.9%
11/46
|
|
Infections and infestations
Nasopharyngitis
|
23.4%
11/47
|
23.9%
11/46
|
|
Infections and infestations
Urinary tract infection
|
2.1%
1/47
|
10.9%
5/46
|
|
Investigations
Blood creatine phosphokinase increased
|
2.1%
1/47
|
13.0%
6/46
|
|
Investigations
Blood creatinine increased
|
17.0%
8/47
|
0.00%
0/46
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/47
|
10.9%
5/46
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/47
|
13.0%
6/46
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.4%
3/47
|
13.0%
6/46
|
|
Renal and urinary disorders
Proteinuria
|
6.4%
3/47
|
32.6%
15/46
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.1%
9/47
|
17.4%
8/46
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.1%
1/47
|
13.0%
6/46
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/47
|
10.9%
5/46
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: +1 (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 or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER