Trial Outcomes & Findings for A Trial Comparing Prograf and Neoral Use in Kidney Transplant Recipients of Hispanic Ethnicity (NCT NCT00983645)
NCT ID: NCT00983645
Last Updated: 2016-06-03
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
15 participants
Primary outcome timeframe
6 months post-transplant
Results posted on
2016-06-03
Participant Flow
Participant milestones
| Measure |
Neoral
Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants
Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID
|
Prograf
Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.
Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
|
Overall Study
COMPLETED
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial Comparing Prograf and Neoral Use in Kidney Transplant Recipients of Hispanic Ethnicity
Baseline characteristics by cohort
| Measure |
Neoral
n=8 Participants
Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants
Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID
|
Prograf
n=7 Participants
Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.
Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.875 years
n=99 Participants
|
42.14 years
n=107 Participants
|
35.6 years
n=206 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=99 Participants
|
7 participants
n=107 Participants
|
15 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 months post-transplantPopulation: Data cannot be located for analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months post-transplantPopulation: Data cannot be located for analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months post-transplantPopulation: Data cannot be located for analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months post-transplantPopulation: Data cannot be located for analysis.
Outcome measures
Outcome data not reported
Adverse Events
Neoral
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Prograf
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Pedro Baron
Loma Linda University Medical Center Transplantation Institute
Phone: 909-558-3636
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place