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Sirolimus Associated With Tacrolimus at Low Doses in Elderly Kidney Transplant Patients

11. februar 2016 opdateret af: Luis Gustavo Modelli de Andrade, Associação Médico Espírita de Botucatu

Sirolimus Associated With Tacrolimus at Low Doses in Elderly Kidney Transplant Patients: A Prospective Randomized Controlled Trial

There is no consensus on the best immunosuppressive regimen in elderly people. The aim of this study will be to evaluate the efficacy of sirolimus associated with tacrolimus in elderly kidney transplant recipients. The investigators will conduct a single-center prospective randomized study comparing the combination of tacrolimus with sirolimus at reduced dose rate (tacrolimus + sirolimus group) against tacrolimus with mycophenolate (tacrolimus + mycophenolate group). The investigators will include all kidney transplant patients over 60 years of age. The investigators will evaluate estimated glomerular filtration rate and incidence of cytomegalovirus in 12 month follow-up.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

48

Fase

  • Fase 4

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

60 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

1. Patients aged more than 60 years and recipients of compatible renal transplant

Exclusion Criteria:

  1. Receptors of multiple organs;
  2. non-heart beating donors;
  3. donors aged under 5 or over 65 years;
  4. Patients with body mass index greater than 35

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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 %
Medicin: tacrolimus
Andre navne:
  • Prograf
  • FK506
Medicin: mycophenolate
Andre navne:
  • Myfortic
  • Mycophenolat natrium
Medicin: Prednisone
Prednisone 30mg/day
Andre navne:
  • Meticorten
Medicin: Basiliximab
Basiliximab 20mg (first and fourth day) if panel reactivity class I less than 50 %
Andre navne:
  • Simulect
Medicin: Thymoglobulin
Thymoglobulin at a dose of 1mg/kg for 5 days if panel reactivity class I greater than 50 %
Andre navne:
  • antithymocyt globulin
Eksperimentel: 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 %
Medicin: tacrolimus
Andre navne:
  • Prograf
  • FK506
Medicin: Prednisone
Prednisone 30mg/day
Andre navne:
  • Meticorten
Medicin: Basiliximab
Basiliximab 20mg (first and fourth day) if panel reactivity class I less than 50 %
Andre navne:
  • Simulect
Medicin: Thymoglobulin
Thymoglobulin at a dose of 1mg/kg for 5 days if panel reactivity class I greater than 50 %
Andre navne:
  • antithymocyt globulin
Medicin: sirolimus
Andre navne:
  • Rapamycin
  • Rapamune

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in estimated glomerular filtration rate from baseline
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of cytomegalovirus Infection (CMV)
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Associação Médico Espírita de Botucatu

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2014

Primær færdiggørelse (Faktiske)

1. januar 2015

Studieafslutning (Faktiske)

1. januar 2016

Datoer for studieregistrering

Først indsendt

5. februar 2016

Først indsendt, der opfyldte QC-kriterier

11. februar 2016

Først opslået (Skøn)

17. februar 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

17. februar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. februar 2016

Sidst verificeret

1. februar 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 16966913.6.0000.5411

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Kliniske forsøg med Cytomegalovirus infektioner

Kliniske forsøg med tacrolimus

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