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Trial Outcomes & Findings for A Study Comparing the Withdrawal of Steroids or Tacrolimus in Kidney Transplant Recipients (NCT NCT00195429)

NCT ID: NCT00195429

Last Updated: 2023-12-11

Results Overview

Diagnosis of acute rejection was made via kidney biopsy using the Banff criteria (a standardized model for interpretation of renal allograft biopsies).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

47 participants

Primary outcome timeframe

12 months

Results posted on

2023-12-11

Participant Flow

Subjects were recruited in Brazil from August 2005 to September 2006.

After renal transplantation subjects were immediately randomized into day 1.

Participant milestones

Participant milestones
Measure
Sirolimus + Tacrolimus
Sirolimus + Prednisone
Overall Study
STARTED
24
23
Overall Study
COMPLETED
19
18
Overall Study
NOT COMPLETED
5
5

Reasons for withdrawal

Reasons for withdrawal
Measure
Sirolimus + Tacrolimus
Sirolimus + Prednisone
Overall Study
Adverse Event
2
4
Overall Study
Lack of Efficacy
2
1
Overall Study
Lost to Follow-up
1
0

Baseline Characteristics

A Study Comparing the Withdrawal of Steroids or Tacrolimus in Kidney Transplant Recipients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Sirolimus + Tacrolimus
n=24 Participants
Sirolimus + Prednisone
n=23 Participants
Total
n=47 Participants
Total of all reporting groups
Age, Continuous
35.3 years
STANDARD_DEVIATION 11.3 • n=99 Participants
34.7 years
STANDARD_DEVIATION 12.2 • n=107 Participants
35.0 years
STANDARD_DEVIATION 11.6 • n=206 Participants
Sex: Female, Male
Female
8 Participants
n=99 Participants
12 Participants
n=107 Participants
20 Participants
n=206 Participants
Sex: Female, Male
Male
16 Participants
n=99 Participants
11 Participants
n=107 Participants
27 Participants
n=206 Participants

PRIMARY outcome

Timeframe: 12 months

Population: The population that was used for this analysis was the transplantation recipient population, which included all randomized patients.

Diagnosis of acute rejection was made via kidney biopsy using the Banff criteria (a standardized model for interpretation of renal allograft biopsies).

Outcome measures

Outcome measures
Measure
Sirolimus + Tacrolimus
n=24 Participants
Sirolimus + Prednisone
n=23 Participants
Number of Patients With Biopsy Confirmed Acute Rejection at 12 Months Follow up.
Subjects with Acute Rejection
3 participants
3 participants
Number of Patients With Biopsy Confirmed Acute Rejection at 12 Months Follow up.
Subjects without Acute Rejection
21 participants
20 participants

SECONDARY outcome

Timeframe: 12 months

Population: The population that was used for this analysis was patients who completed 12 months.

Creatinine clearance is a measure of kidney function. Creatinine clearance rate (CCr) is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, CCr was calculated using the Nakivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females, 90-125 ml/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.

Outcome measures

Outcome measures
Measure
Sirolimus + Tacrolimus
n=19 Participants
Sirolimus + Prednisone
n=18 Participants
Creatinine Clearance Rate
60 ml/min
Standard Deviation 11.5
63.4 ml/min
Standard Deviation 10.5

Adverse Events

Sirolimus + Tacrolimus

Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths

Sirolimus + Prednisone

Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Sirolimus + Tacrolimus
n=24 participants at risk
Sirolimus + Prednisone
n=23 participants at risk
Infections and infestations
Infection Disease
79.2%
19/24
82.6%
19/23
Vascular disorders
Hypertension
4.2%
1/24
4.3%
1/23
Metabolism and nutrition disorders
Diabetes Mellitus post-transplant
12.5%
3/24
8.7%
2/23

Additional Information

U. S. Contact Center

Wyeth

Results disclosure agreements

  • Principal investigator is a sponsor employee The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
  • Publication restrictions are in place

Restriction type: OTHER