Study Evaluating The Use Of Sirolimus In Recipients Of Kidney Allografts From Expanded Criteria Donors (ECD)

Renal Transplantation Clinical Trial

Official title:

Surveillance Registry Of Sirolimus Use In Recipients Of Kidney Allograft From Expanded Criteria Donors (ECD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00697112
• Other study ID #: 0468H-102385
• Secondary ID: B1741025
• Status: Completed
• Phase: N/A
• First received: June 10, 2008
• Last updated: December 3, 2013
• Start date: May 2008
• Est. completion date: December 2012

Study information

• Verified date: December 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Observational

Clinical Trial 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.

Description:

pilot study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Renal Transplantation

Intervention

Drug:
• Sirolimus
Non interventional. Sirolimus administered by Principal Investigator per standard practice and labeling.

Locations

Country	Name	City	State
Argentina	Pfizer Investigational Site	Barrio General Paz	Cordoba
Argentina	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	Pfizer Investigational Site	Cordoba
Argentina	Pfizer Investigational Site	Santa Fe
Argentina	Pfizer Investigational Site	Tucuman

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline	No
Secondary	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.	Month 12	No
Secondary	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.	Month 12	No
Secondary	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.	Month 12	No
Secondary	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).	Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53	No
Secondary	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).	Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53	No
Secondary	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.	Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53	No
Secondary	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).	Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53	No
Secondary	Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy		Baseline up to Month 12	No
Secondary	Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy Due to Inefficacy		Baseline up to Month 12	No
Secondary	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.	Baseline up to Month 12	Yes
Secondary	Body Mass Index	BMI was calculated as weight divided by height squared and measured as kilogram per square meter (kg/m^2).	Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53	Yes
Secondary	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.	Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53	Yes
Secondary	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).	Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53	Yes
Secondary	Pulse Rate		Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53	Yes
Secondary	Body Weight		Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53	Yes
Secondary	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.	Baseline up to Month 12	Yes
Secondary	Percentage of Participants With Adverse Events	An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.	Baseline up to Month 12	Yes
Secondary	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.	Baseline up to Month 12	Yes
Secondary	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]).	Baseline up to Month 12	Yes
Secondary	Percentage of Participants With Clinically-Significant Radiological Abnormalities	Radiological examination was performed to evaluate presence or signs of infections or pneumonitis.	Baseline up to Month 12	Yes

External Links

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