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.
pilot study
Study Type
OBSERVATIONAL
Enrollment
53
Non interventional. Sirolimus administered by Principal Investigator per standard practice and labeling.
Pfizer Investigational Site
Caba, Buenos Aires, Argentina
Pfizer Investigational Site
Caba, Buenos Aires, Argentina
Pfizer Investigational Site
Caba, Buenos Aires, Argentina
Pfizer Investigational Site
Caba, Buenos Aires, Argentina
Percentage of Participants With Main Reason for the Use of Sirolimus (Rapamune) Therapy
The study employ a questionnaire which included different clinical criteria to determine the main medical reason for the introduction of sirolimus (Rapamune) therapy after renal transplant. The physician responsible selected the one that was considered the main reason for introduction of sirolimus (Rapamune) as base immunosuppressive therapy.
Time frame: Baseline
Probability of Graft Survival
Graft survival was considered in participants who did not experience graft failure. Graft failure was determined by return to dialysis for a period of at least 12 weeks with no return of function, or graft loss whichever occurred sooner.
Time frame: Month 12
Probability of no Acute Rejection
Diagnosis of acute rejection was made via kidney biopsy. Categorization of biopsies with suspected acute rejection was based on histological findings using updated 1997 Banff criteria: Grade 1A: significant interstitial infiltration (greater than \[\>\] 25 percent \[%\] of parenchyma affected) and foci of moderate tubulitis (5-10 cells/tubular cross section), Grade 1B: significant interstitial infiltration (\>25% of parenchyma affected) and severe tubulitis (\>10 mononuclear cells/tubular cross section), Grade 2A: mild-moderate intimal arteritis, Grade 2B: severe intimal arteritis comprising \>25% of the luminal area and Grade 3: transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells. Probability of no acute rejection throughout the sirolimus (Rapamune) therapy was estimated using Kaplan-Meier method.
Time frame: Month 12
Probability of Participant Survival
Participant's survival defined as participant living with or without a functioning graft. Probability of participant survival throughout the sirolimus (Rapamune) therapy was estimated using Kaplan-Meier method.
Time frame: Month 12
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Pfizer Investigational Site
Barrio General Paz, Córdoba Province, Argentina
Pfizer Investigational Site
Santa Fe, Santa Fe Province, Argentina
Pfizer Investigational Site
San Miguel de Tucumán, Tucumán Province, Argentina
Pfizer Investigational Site
Córdoba, Argentina
Average Dose of Immunosuppressive Drugs Administered
Immunosuppressive drugs administered included cyclosporin A (CsA) administration based on monitoring of plasma trough levels (C0), CsA administration based on monitoring of plasma levels 2-hours after CsA dose (C2), tacrolimus, and sirolimus (Rapamune).
Time frame: Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53
Average Blood Level of Immunosuppressive Drugs Administered
Immunosuppressive drugs administered included cyclosporin A (CsA) administration based on monitoring of plasma trough levels (C0), CsA administration based on monitoring of plasma levels 2-hours after CsA dose (C2), tacrolimus, and sirolimus (Rapamune).
Time frame: Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53
Average Creatinine Clearance
Creatinine clearance (CCr) is a measure of glomerular filtration rate (GMFR), an index of kidney function. CCr is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 milliliter per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.
Time frame: Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53
Average Proteinuria
Proteinuria defined as the presence of an excess of serum proteins in the urine. Normal value of proteinuria is below 0.15 grams per 24 hours (g/24 hr).
Time frame: Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53
Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy
Time frame: Baseline up to Month 12
Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy Due to Inefficacy
Time frame: Baseline up to Month 12
Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy Due to Adverse Events
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Participants who discontinued sirolimus (Rapamune) therapy prematurely due to AE were obliged to discontinue sirolimus (Rapamune) therapy permanently, are reported.
Time frame: Baseline up to Month 12
Body Mass Index
BMI was calculated as weight divided by height squared and measured as kilogram per square meter (kg/m\^2).
Time frame: Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53
Number of Participants With Body Temperature
Body temperature was measured in degree Celsius. Each participants were classified into three different categories based on their body temperature: body temperature less than 35 degree Celsius = hypothermia, body temperature between 35 to 37.5 degree Celsius = feverless, and body temperature greater than 37.5 degree Celsius = fever.
Time frame: Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53
Blood Pressure
Systolic and diastolic blood pressure (BP) was measured after the participant had rested in the supine position for at least 5 minutes with the participant's arm supported at the level of the heart, and recorded to the nearest millimeters of mercury (mmHg).
Time frame: Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53
Pulse Rate
Time frame: Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53
Body Weight
Time frame: Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53
Percentage of Participants With Physical Abnormalities
Physical abnormalities included all the abnormalities related to general disorders and administration site conditions, gastrointestinal disorders, skin and subcutaneous tissue disorders, vascular disorders, investigations, infections and infestations, eye disorders, respiratory, thoracic and mediastinal disorders, nervous system disorders, musculoskeletal and connective tissue disorders, injury, poisoning and procedural complications, surgical and medical procedures, psychiatric disorders, neoplasms benign, malignant and unspecified (incl cysts and polyps), ear and labyrinth disorders, and congenital, familial and genetic disorders.
Time frame: Baseline up to Month 12
Percentage of Participants With Adverse Events
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.
Time frame: Baseline up to Month 12
Percentage of Participants With Serious Adverse Events
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: Baseline up to Month 12
Percentage of Participants With Clinically-Significant Electrocardiogram Abnormalities
Standard 12-lead ECG was performed. ECG intervals included PR interval (time between the onset of atrial depolarization and the onset of ventricular depolarization), QRS interval (represented ventricular depolarization), QT interval (time corresponding to the beginning of depolarization to repolarization of the ventricles) corrected using Fridericia's formula (QTcF = QT divided by cube root of RR interval) and heart rate (time interval between consecutive heart beats \[RR interval\]).
Time frame: Baseline up to Month 12
Percentage of Participants With Clinically-Significant Radiological Abnormalities
Radiological examination was performed to evaluate presence or signs of infections or pneumonitis.
Time frame: Baseline up to Month 12