Clinical trial NCT00697112: Study Evaluating The Use Of Sirolimus In Recipients Of Kidney Allografts From Expanded Criteria Donors (ECD)
Official title: Surveillance Registry Of Sirolimus Use In Recipients Of Kidney Allograft From Expanded Criteria Donors (ECD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Transplantation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-06-13
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kidney allograft recipients

Brief summary: The purpose of this observational study is to examine the clinical outcomes of the use of sirolimus as base therapy in kidney allograft recipients from Expanded Criteria Donors (ECD) under conditions of routine clinical practice. The primary objective is to identify the current criteria/reasons to use sirolimus as base therapy in this selected population and define and understand the emerging patterns of immunosuppressive treatment with sirolimus.

Detailed description: pilot study

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older.
* Patients who received a renal transplant (primary, secondary, tertiary, etc.) without pancreas, from Expanded Criteria Donors (ECD), 3 months prior and no later than 1 year at the time of study enrollment.
* Patients who provided informed consent.
* Patients without sirolimus as base therapy.

Exclusion Criteria:

* Patients who are unwilling or unable to provide informed consent or who lack a legal guardian or designee able to provide consent on their behalf.
* Patients who are unable to complete the study.
* Patients who are participating in another clinical trial during the last 6 months.
* Pregnant or lactating patients.

Primary outcomes:
measure: Percentage of Participants With Main Reason for the Use of Sirolimus (Rapamune) Therapy
timeFrame: Baseline
Secondary outcomes:
measure: Probability of Graft Survival
timeFrame: Month 12
measure: Probability of no Acute Rejection
timeFrame: Month 12
measure: Probability of Participant Survival
timeFrame: Month 12
measure: Average Dose of Immunosuppressive Drugs Administered
timeFrame: Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53
measure: Average Blood Level of Immunosuppressive Drugs Administered
timeFrame: Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53
measure: Average Creatinine Clearance
timeFrame: Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53
measure: Average Proteinuria
timeFrame: Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53
measure: Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy
timeFrame: Baseline up to Month 12
measure: Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy Due to Inefficacy
timeFrame: Baseline up to Month 12
measure: Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy Due to Adverse Events
timeFrame: Baseline up to Month 12
measure: Body Mass Index
timeFrame: Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53
measure: Number of Participants With Body Temperature
timeFrame: Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53
measure: Blood Pressure
timeFrame: Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53
measure: Pulse Rate
timeFrame: Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53
measure: Body Weight
timeFrame: Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53
measure: Percentage of Participants With Physical Abnormalities
timeFrame: Baseline up to Month 12
measure: Percentage of Participants With Adverse Events
timeFrame: Baseline up to Month 12
measure: Percentage of Participants With Serious Adverse Events
timeFrame: Baseline up to Month 12
measure: Percentage of Participants With Clinically-Significant Electrocardiogram Abnormalities
timeFrame: Baseline up to Month 12
measure: Percentage of Participants With Clinically-Significant Radiological Abnormalities
timeFrame: Baseline up to Month 12
Other outcomes:
Locations:
city: Caba
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Barrio General Paz
country: Argentina
facility: Pfizer Investigational Site
state: Cordoba
city: Cordoba
country: Argentina
facility: Pfizer Investigational Site
city: Santa Fe
country: Argentina
facility: Pfizer Investigational Site
city: Tucuman
country: Argentina
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: