Trial Outcomes & Findings for Comparison of Sirolimus and Azathioprine in Lung Transplantation (NCT NCT00321906)
NCT ID: NCT00321906
Last Updated: 2016-09-21
Results Overview
Raw proportion of patients that experienced acute rejection at or before 12 months.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
181 participants
Primary outcome timeframe
12mos
Results posted on
2016-09-21
Participant Flow
Participant milestones
| Measure |
Azathioprine
(tacrolimus,azathioprine/prednisone)
|
Sirolimus
tacrolimus/sirolimus/prednisone
|
|---|---|---|
|
Overall Study
STARTED
|
94
|
87
|
|
Overall Study
COMPLETED
|
48
|
31
|
|
Overall Study
NOT COMPLETED
|
46
|
56
|
Reasons for withdrawal
| Measure |
Azathioprine
(tacrolimus,azathioprine/prednisone)
|
Sirolimus
tacrolimus/sirolimus/prednisone
|
|---|---|---|
|
Overall Study
Adverse Event
|
36
|
44
|
|
Overall Study
Death
|
9
|
6
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
Baseline Characteristics
Comparison of Sirolimus and Azathioprine in Lung Transplantation
Baseline characteristics by cohort
| Measure |
Azathioprine
n=94 Participants
(tacrolimus,azathioprine/prednisone)
|
Sirolimus
n=87 Participants
tacrolimus/sirolimus/prednisone
|
Total
n=181 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
57 years
n=7 Participants
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12mosRaw proportion of patients that experienced acute rejection at or before 12 months.
Outcome measures
| Measure |
Azathioprine
n=94 Participants
(tacrolimus,azathioprine/prednisone)
|
Sirolimus
n=87 Participants
tacrolimus/sirolimus/prednisone
|
|---|---|---|
|
Acute Rejection Rate at 12 Months
|
48 percentage of participants
|
39 percentage of participants
|
SECONDARY outcome
Timeframe: 12 mosPopulation: The analysis population included patients who underwent at least one transbronchial biopsy.
Kaplan-Meier estimate of proportion of patients that had not experienced acute rejection by 12 months. Acute rejection is defined as rejection at any of the following grades. Grade A0 - None With/Without Grade A1 - Minimal Grade A2 - Mild Grade A3 - Moderate
Outcome measures
| Measure |
Azathioprine
n=89 Participants
(tacrolimus,azathioprine/prednisone)
|
Sirolimus
n=76 Participants
tacrolimus/sirolimus/prednisone
|
|---|---|---|
|
Acute Rejection-free Survival at 12 Months
|
56 percentage of participants
|
58 percentage of participants
|
SECONDARY outcome
Timeframe: 12 mosRaw proportion of patients that experienced rejection at or above grade A2 by 12 months. Grade A0 - None With/Without Grade A1 - Minimal Grade A2 - Mild Grade A3 - Moderate
Outcome measures
| Measure |
Azathioprine
n=94 Participants
(tacrolimus,azathioprine/prednisone)
|
Sirolimus
n=87 Participants
tacrolimus/sirolimus/prednisone
|
|---|---|---|
|
Severity of Acute Rejection at 12 Months
|
24 percentage of participants
|
18 percentage of participants
|
SECONDARY outcome
Timeframe: 24 mosKaplan-Meier estimate of proportion of patients that had not experienced BOS by 24 months.
Outcome measures
| Measure |
Azathioprine
n=94 Participants
(tacrolimus,azathioprine/prednisone)
|
Sirolimus
n=87 Participants
tacrolimus/sirolimus/prednisone
|
|---|---|---|
|
Bronchiolitis Obliterans Syndrome (BOS) at 24 Months
|
81 percentage of participants
|
78 percentage of participants
|
SECONDARY outcome
Timeframe: 36 mosKaplan-Meier estimate of proportion of patients that had not experienced BOS by 36 months.
Outcome measures
| Measure |
Azathioprine
n=94 Participants
(tacrolimus,azathioprine/prednisone)
|
Sirolimus
n=87 Participants
tacrolimus/sirolimus/prednisone
|
|---|---|---|
|
Bronchiolitis Obliterans Syndrome (BOS) at 36 Months
|
76 percentage of participants
|
72 percentage of participants
|
SECONDARY outcome
Timeframe: 12 mosKaplan-Meier estimate of proportion of patients that survived to (i.e., had not died by) 12 months.
Outcome measures
| Measure |
Azathioprine
n=94 Participants
(tacrolimus,azathioprine/prednisone)
|
Sirolimus
n=87 Participants
tacrolimus/sirolimus/prednisone
|
|---|---|---|
|
Overall Survival at 12 Months
|
97 percentage of participants
|
97 percentage of participants
|
SECONDARY outcome
Timeframe: 24 mosKaplan-Meier estimate of proportion of patients that survived to (i.e., had not died by) 24 months.
Outcome measures
| Measure |
Azathioprine
n=94 Participants
(tacrolimus,azathioprine/prednisone)
|
Sirolimus
n=87 Participants
tacrolimus/sirolimus/prednisone
|
|---|---|---|
|
Overall Survival at 24 Months
|
89 percentage of participants
|
94 percentage of participants
|
SECONDARY outcome
Timeframe: 36 mosKaplan-Meier estimate of proportion of patients that survived to (i.e., had not died by) 36 months.
Outcome measures
| Measure |
Azathioprine
n=94 Participants
(tacrolimus,azathioprine/prednisone)
|
Sirolimus
n=87 Participants
tacrolimus/sirolimus/prednisone
|
|---|---|---|
|
Overall Survival at 36 Months
|
84 percentage of participants
|
87 percentage of participants
|
Adverse Events
Azathioprine
Serious events: 32 serious events
Other events: 94 other events
Deaths: 0 deaths
Sirolimus
Serious events: 47 serious events
Other events: 87 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Azathioprine
n=94 participants at risk
(tacrolimus,azathioprine/prednisone)
|
Sirolimus
n=87 participants at risk
tacrolimus/sirolimus/prednisone
|
|---|---|---|
|
Investigations
Renal insufficiency or increased creatinine level
|
12.8%
12/94 • 3 years post-transplant
|
23.0%
20/87 • 3 years post-transplant
|
|
Blood and lymphatic system disorders
Anemia/Leukopenia
|
7.4%
7/94 • 3 years post-transplant
|
13.8%
12/87 • 3 years post-transplant
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.2%
3/94 • 3 years post-transplant
|
2.3%
2/87 • 3 years post-transplant
|
|
Respiratory, thoracic and mediastinal disorders
Declining pulmonary function
|
5.3%
5/94 • 3 years post-transplant
|
5.7%
5/87 • 3 years post-transplant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignancy
|
5.3%
5/94 • 3 years post-transplant
|
6.9%
6/87 • 3 years post-transplant
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/94 • 3 years post-transplant
|
1.1%
1/87 • 3 years post-transplant
|
|
Infections and infestations
Viral infection
|
0.00%
0/94 • 3 years post-transplant
|
1.1%
1/87 • 3 years post-transplant
|
|
Infections and infestations
Eyelash infection
|
16.0%
15/94 • 3 years post-transplant
|
3.4%
3/87 • 3 years post-transplant
|
|
Cardiac disorders
Love
|
3.2%
3/94 • 3 years post-transplant
|
4.6%
4/87 • 3 years post-transplant
|
|
Nervous system disorders
Fear of handshakes
|
0.00%
0/94 • 3 years post-transplant
|
1.1%
1/87 • 3 years post-transplant
|
Other adverse events
| Measure |
Azathioprine
n=94 participants at risk
(tacrolimus,azathioprine/prednisone)
|
Sirolimus
n=87 participants at risk
tacrolimus/sirolimus/prednisone
|
|---|---|---|
|
Metabolism and nutrition disorders
Dyslipidemia
|
42.6%
40/94 • 3 years post-transplant
|
67.8%
59/87 • 3 years post-transplant
|
|
Metabolism and nutrition disorders
Severe hypertriglyceridemia (.500 mg/dl)
|
3.2%
3/94 • 3 years post-transplant
|
14.9%
13/87 • 3 years post-transplant
|
|
Gastrointestinal disorders
Abdominal pain
|
12.8%
12/94 • 3 years post-transplant
|
16.1%
14/87 • 3 years post-transplant
|
|
Gastrointestinal disorders
Nausea
|
3.2%
3/94 • 3 years post-transplant
|
9.2%
8/87 • 3 years post-transplant
|
|
Gastrointestinal disorders
Diarrhea
|
5.3%
5/94 • 3 years post-transplant
|
12.6%
11/87 • 3 years post-transplant
|
|
Renal and urinary disorders
Renal insufficiency or increased creatinine level
|
22.3%
21/94 • 3 years post-transplant
|
16.1%
14/87 • 3 years post-transplant
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
48.9%
46/94 • 3 years post-transplant
|
60.9%
53/87 • 3 years post-transplant
|
|
Blood and lymphatic system disorders
Anemia/Leukopenia
|
27.7%
26/94 • 3 years post-transplant
|
21.8%
19/87 • 3 years post-transplant
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.7%
11/94 • 3 years post-transplant
|
17.2%
15/87 • 3 years post-transplant
|
|
Respiratory, thoracic and mediastinal disorders
Declining pulmonary function
|
10.6%
10/94 • 3 years post-transplant
|
10.3%
9/87 • 3 years post-transplant
|
|
General disorders
Persistent acute rejection
|
9.6%
9/94 • 3 years post-transplant
|
4.6%
4/87 • 3 years post-transplant
|
|
Vascular disorders
Thromboembolic disease
|
3.2%
3/94 • 3 years post-transplant
|
17.2%
15/87 • 3 years post-transplant
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial stenosis
|
17.0%
16/94 • 3 years post-transplant
|
23.0%
20/87 • 3 years post-transplant
|
|
General disorders
Pedal edema
|
1.1%
1/94 • 3 years post-transplant
|
6.9%
6/87 • 3 years post-transplant
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.1%
1/94 • 3 years post-transplant
|
5.7%
5/87 • 3 years post-transplant
|
|
Blood and lymphatic system disorders
Excess bleeding
|
1.1%
1/94 • 3 years post-transplant
|
5.7%
5/87 • 3 years post-transplant
|
|
Infections and infestations
Bacterial infection
|
33.0%
31/94 • 3 years post-transplant
|
43.7%
38/87 • 3 years post-transplant
|
|
Infections and infestations
Viral infection
|
27.7%
26/94 • 3 years post-transplant
|
25.3%
22/87 • 3 years post-transplant
|
|
Infections and infestations
Fungal infection
|
18.1%
17/94 • 3 years post-transplant
|
23.0%
20/87 • 3 years post-transplant
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place