Sirolimus Associated With Tacrolimus at Low Doses in Elderly Kidney Transplant Patients
Sirolimus Associated With Tacrolimus at Low Doses in Elderly Kidney Transplant Patients: A Prospective Randomized Controlled Trial
Studie Overzicht
Toestand
Gedetailleerde beschrijving
Study Design
This will be a single-center, prospective, 12-month randomized controlled trial aiming to compare sirolimus associated with tacrolimus in elderly renal transplant patients as to safety and incidence of cytomegalovirus (CMV) infection.
Treatments
In the control group (Tacrolimus + Mycophenolate) the investigators will use tacrolimus (starting with 0.1 mg/kg twice daily adjusted to target serum levels by 4-8ng/ml at the third month and then 3-7ng/ml from the third month to the 12th month) and mycophenolate sodium 720 mg twice daily. A dose reduction of mycophenolate sodium to 720 mg/day will be accepted due to possible side effects of the drug.
In the treatment group (Tacrolimus + sirolimus) the investigators will use tacrolimus (starting with 0.1 mg/kg twice daily adjusted to target serum levels by 4-8 ng/ml at the third month and then 3-7 ng/ml from the third month to the 12th month) and sirolimus 2 mg/day (adjusted serum levels at 4-8 ng/ml throughout the study period).
In all groups, patients will receive prednisone 30 mg/day (in the first month with weekly reductions up to 5 mg/day at the end of the second month). Induction therapy consisted of basiliximab or antithymocyte globulin (Thymoglobulin, Genzyme®). Thymoglobulin will be used in patients with panel reactivity class I greater than 50 % (at a dose of 1mg/kg for 5 days).
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 4
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
1. Patients aged more than 60 years and recipients of compatible renal transplant
Exclusion Criteria:
- Receptors of multiple organs;
- non-heart beating donors;
- donors aged under 5 or over 65 years;
- Patients with body mass index greater than 35
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: Tacrolimus + Mycophenolate
The investigators wil be used tacrolimus (starting with 0.1 mg/kg twice daily adjusted to target serum levels by 4-8ng/ml at the third month and then 3-7ng/ml from the third month to the 12th month) and mycophenolate sodium 720 mg twice daily. A dose reduction of mycophenolate sodium to 720 mg/day will be accepted due to possible side effects of the drug. Prednisone 30 mg/day in the first month. Induction therapy consisted of basiliximab or thymoglobulin if panel reactivity class I greater than 50 % |
Andere namen:
Andere namen:
Prednisone 30mg/day
Andere namen:
Basiliximab 20mg (first and fourth day) if panel reactivity class I less than 50 %
Andere namen:
Thymoglobulin at a dose of 1mg/kg for 5 days if panel reactivity class I greater than 50 %
Andere namen:
|
|
Experimenteel: Tacrolimus + Sirolimus
The investigators will be used tacrolimus (starting with 0.1 mg/kg twice daily adjusted to target serum levels by 4-8 ng/ml at the third month and then 3-7 ng/ml from the third month to the 12th month) and sirolimus 2 mg/day (adjusted serum levels at 4-8 ng/ml throughout the study period). Prednisone 30 mg/day in the first month. Induction therapy consisted of basiliximab or thymoglobulin if panel reactivity class I greater than 50 % |
Andere namen:
Prednisone 30mg/day
Andere namen:
Basiliximab 20mg (first and fourth day) if panel reactivity class I less than 50 %
Andere namen:
Thymoglobulin at a dose of 1mg/kg for 5 days if panel reactivity class I greater than 50 %
Andere namen:
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in estimated glomerular filtration rate from baseline
Tijdsspanne: Baseline, 1 month, 3 months, 6 months and 12 months
|
The primary end-point will be evaluated the estimated glomerular filtration rate (eGFR) over 12 months of renal transplantation.
The investigators will be measure the change in eGFR during 12 month follow-up.
Glomerular filtration rate will be estimated by the MDRD equation (Modification of Diet in Renal Disease).
|
Baseline, 1 month, 3 months, 6 months and 12 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Incidence of cytomegalovirus Infection (CMV)
Tijdsspanne: Weekly from baseline until the third month. After in 4, 5, 6, 8, 10 and 12 months.
|
The secondary end-point will be evaluated the incidence of cytomegalovirus (CMV) infection.
CMV infection will be defined based on detection of CMV viral replication (CMV pp65 antigenemia more than zero) in asymptomatic patients.
CMV disease will be defined based on the evidence of CMV infection with related symptoms.
For the positive cases treatment will be carried out with ganciclovir 5 mg/kg/day twice daily adjusted for renal function for a minimum of 14 days.
|
Weekly from baseline until the third month. After in 4, 5, 6, 8, 10 and 12 months.
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Virusziekten
- Infecties
- DNA-virusinfecties
- Herpesviridae-infecties
- Cytomegalovirusinfecties
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Anti-infectieuze middelen
- Enzymremmers
- Ontstekingsremmende middelen
- Antineoplastische middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Glucocorticoïden
- Hormonen
- Hormonen, hormoonvervangers en hormoonantagonisten
- Antineoplastische middelen, hormonaal
- Antibacteriële middelen
- Antibiotica, antineoplastiek
- Antischimmelmiddelen
- Antituberculeuze middelen
- Antibiotica, antituberculair
- Calcineurineremmers
- Prednison
- Tacrolimus
- Mycofenolzuur
- Sirolimus
- Basiliximab
- Thymoglobuline
- Antilymfocyten Serum
Andere studie-ID-nummers
- 16966913.6.0000.5411
Plan Individuele Deelnemersgegevens (IPD)
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