Trial Outcomes & Findings for Optima: Optimizing Prograf Therapy in Maintenance Allografts II (NCT NCT00905515)
NCT ID: NCT00905515
Last Updated: 2023-09-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
63 participants
Primary outcome timeframe
3 years
Results posted on
2023-09-07
Participant Flow
Participant milestones
| Measure |
Remaining on CsA
Stable transplant recipients randomly assigned to continue on Cyclosporine (CsA( with a target trough level of 50-250 ng/mL.
|
Reduced TAC
Stable transplant recipients randomly assigned to convert to "reduced" Tacrolimus (TAC) with target trough levels 3.0-5.9 ng/mL.
|
Standard TAC
Stable transplant recipients randomly assigned to convert to "standard" TAC with target trough levels of 6.0-8.9 ng/mL.
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
22
|
|
Overall Study
COMPLETED
|
19
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optima: Optimizing Prograf Therapy in Maintenance Allografts II
Baseline characteristics by cohort
| Measure |
Remaining on CsA
n=21 Participants
Patients remained on CSA and were not converted to TAC.
|
Reduced TAC
n=20 Participants
Patients converted from CsA to TAC with trough concentrations 3.0-5.9 ng/mL
|
Standard TAC
n=22 Participants
Patients were converted from CsA to TAC with trough concentrations of 6.0-8.9 ng/mL
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Age, Continuous
|
57.65 years
STANDARD_DEVIATION 12.036 • n=5 Participants
|
58.57 years
STANDARD_DEVIATION 12.023 • n=7 Participants
|
59.14 years
STANDARD_DEVIATION 10.011 • n=5 Participants
|
58.48 years
STANDARD_DEVIATION 11.196 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
20 participants
n=7 Participants
|
22 participants
n=5 Participants
|
63 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 3 yearsOutcome measures
| Measure |
Remaining on CsA
n=21 Participants
Stable transplant recipients randomly assigned to continue on CSA with a target trough level of 50-250 ng/mL.
|
Reduced TAC
n=20 Participants
Stable transplant recipients randomly assigned to convert to "reduced" TAC with target trough levels 3.0-5.9 ng/mL.
|
Standard TAC
n=22 Participants
Stable transplant recipients randomly assigned to convert to "standard" TAC with target trough levels of 6.0-8.9 ng/mL.
|
|---|---|---|---|
|
Renal Function in Patients Converted From Cyclosporine to Prograf
|
0.05 Change in serum creatinine (mg/dL)
Interval -0.04 to 0.14
|
0 Change in serum creatinine (mg/dL)
Interval 0.0 to 0.0
|
0.10 Change in serum creatinine (mg/dL)
Interval -0.07 to 0.26
|
PRIMARY outcome
Timeframe: 3 yearsOutcome measures
| Measure |
Remaining on CsA
n=21 Participants
Stable transplant recipients randomly assigned to continue on CSA with a target trough level of 50-250 ng/mL.
|
Reduced TAC
n=20 Participants
Stable transplant recipients randomly assigned to convert to "reduced" TAC with target trough levels 3.0-5.9 ng/mL.
|
Standard TAC
n=22 Participants
Stable transplant recipients randomly assigned to convert to "standard" TAC with target trough levels of 6.0-8.9 ng/mL.
|
|---|---|---|---|
|
Optimal Dose of Calcineurin Inhibitor in Long-term Maintenance Kidney Transplant Patients
|
130.2 ng/dL
Standard Deviation 54.94
|
5.24 ng/dL
Standard Deviation 2.06
|
6.90 ng/dL
Standard Deviation 2.06
|
PRIMARY outcome
Timeframe: 3 yearsOutcome measures
| Measure |
Remaining on CsA
n=21 Participants
Stable transplant recipients randomly assigned to continue on CSA with a target trough level of 50-250 ng/mL.
|
Reduced TAC
n=20 Participants
Stable transplant recipients randomly assigned to convert to "reduced" TAC with target trough levels 3.0-5.9 ng/mL.
|
Standard TAC
n=22 Participants
Stable transplant recipients randomly assigned to convert to "standard" TAC with target trough levels of 6.0-8.9 ng/mL.
|
|---|---|---|---|
|
Change in Risk Factors for Cardiovascular Morbidity and Chronic Graft Dysfunction as Evidenced by Blood Levels of Homocysteine
|
4.75 ng/dL
Standard Deviation 0.82
|
4.72 ng/dL
Standard Deviation 0.52
|
4.89 ng/dL
Standard Deviation 0.33
|
Adverse Events
Remaining on CsA
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Reduced TAC
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Standard TAC
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Remaining on CsA
n=21 participants at risk
Patients remained on CSA and were not converted to TAC.
|
Reduced TAC
n=20 participants at risk
Patients converted from CsA to TAC with trough concentrations 3.0-5.9 ng/mL
|
Standard TAC
n=22 participants at risk
Patients were converted from CsA to TAC with trough concentrations of 6.0-8.9 ng/mL
|
|---|---|---|---|
|
Endocrine disorders
New onset diabetes mellitus
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
0.00%
0/22
|
Other adverse events
| Measure |
Remaining on CsA
n=21 participants at risk
Patients remained on CSA and were not converted to TAC.
|
Reduced TAC
n=20 participants at risk
Patients converted from CsA to TAC with trough concentrations 3.0-5.9 ng/mL
|
Standard TAC
n=22 participants at risk
Patients were converted from CsA to TAC with trough concentrations of 6.0-8.9 ng/mL
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Bone Fracture
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
0.00%
0/22
|
|
Endocrine disorders
Blood Glucose
|
33.3%
7/21 • Number of events 12
|
45.0%
9/20 • Number of events 23
|
36.4%
8/22 • Number of events 17
|
|
Blood and lymphatic system disorders
Anemia
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
4.5%
1/22 • Number of events 1
|
|
Cardiac disorders
Gingival Hypertrophy
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
0.00%
0/22
|
|
Blood and lymphatic system disorders
Absolute Neutrophil
|
4.8%
1/21 • Number of events 1
|
50.0%
10/20 • Number of events 11
|
45.5%
10/22 • Number of events 10
|
|
Endocrine disorders
Hirsutism
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
0.00%
0/22
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place