N/A
Completed N=53
Study Evaluating The Use Of Sirolimus In Recipients Of Kidney Allografts From Expanded Criteria Donors (ECD)
Renal Transplantation
Source: ClinicalTrials.gov NCT00697112 ↗
Enrolled (actual)
53
Serious AEs
40.4%
Results posted
Jan 2014
Primary outcomePrimary: Percentage of Participants With Main Reason for the Use of Sirolimus (Rapamune) Therapy — 40.38; 25.00; 5.77; 5.77 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Main Reason for the Use of Sirolimus (Rapamune) Therapy |
40.38; 25.00; 5.77; 5.77; 5.77; 5.77 | — |
| SECONDARY Probability of Graft Survival |
1 | — |
| SECONDARY Probability of no Acute Rejection |
0.960 | — |
| SECONDARY Probability of Participant Survival |
0.979 | — |
| SECONDARY Average Dose of Immunosuppressive Drugs Administered |
200.00; 306.67; 5.74; 4.79; 2.43; 150.00 | — |
| SECONDARY Average Blood Level of Immunosuppressive Drugs Administered |
144.00; 580.67; 7.82; 8.12; 8.55; 136.00 | — |
| SECONDARY Average Creatinine Clearance |
45.40; 50.56; 51.51; 50.95; 49.52; 53.24 | — |
| SECONDARY Average Proteinuria |
0.17; 0.19; 0.37; 0.48; 0.60; 0.45 | — |
| SECONDARY Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy |
15.38 | — |
| SECONDARY Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy Due to Inefficacy |
— | — |
| SECONDARY Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy Due to Adverse Events |
15.38 | — |
| SECONDARY Body Mass Index |
24.48; 23.74; 24.94; 24.70; 25.01; 24.06 | — |
| SECONDARY Number of Participants With Body Temperature |
21; 26; 25; 16; 1; 17 | — |
| SECONDARY Blood Pressure |
127.8; 77.2; 125.7; 77.6; 127.4; 75.6 | — |
| SECONDARY Pulse Rate |
74.0; 77.4; 77.2; 73.2; 75.3; 76.2 | — |
| SECONDARY Body Weight |
70.78; 71.17; 70.87; 72.85; 72.18; 70.96 | — |
| SECONDARY Percentage of Participants With Physical Abnormalities |
69.23 | — |
| SECONDARY Percentage of Participants With Adverse Events |
88.46 | — |
| SECONDARY Percentage of Participants With Serious Adverse Events |
40.38 | — |
| SECONDARY Percentage of Participants With Clinically-Significant Electrocardiogram Abnormalities |
— | — |
| SECONDARY Percentage of Participants With Clinically-Significant Radiological Abnormalities |
— | — |
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.
Data sourced from ClinicalTrials.gov (NCT00697112). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.