NCT00290069

Brief Summary

The main aim of this study is to compare the renal function (serum creatinine at 6 months) in the later introduction of tacrolimus or rapamycin based in immunosuppressor regimes with daclizumab, mycophenolate mofetil, and steroids in patients older than 50 years of age who are the recipients of a graft from donors aged 55 years and older.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2006

Completed
Last Updated

May 15, 2007

Status Verified

February 1, 2006

First QC Date

February 9, 2006

Last Update Submit

May 14, 2007

Conditions

Kidney DiseasesGraft Rejection

Keywords

Renal functionSerum creatinineImmunosuppressionRejection

Outcome Measures

Primary Outcomes (1)

  • Serum creatinine at 6 months

Secondary Outcomes (5)

  • Calculated creatinine clearance (Cockroft Gault)

  • Acute rejection rate at 6 months and time until first rejection

  • Patient and graft survival at 6 months

  • Rate and length of the delay in the graft function defined as dialysis in the first week post-transplant

  • Treatment failure at 6 months

Interventions

TacrolimusDRUG
RapamycinDRUG

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both male and female patients older than 50 years who are primary recipients of a renal allograft from a donor older than 55 years.
  • Patients who have given their consent previously to their participation in the study.

You may not qualify if:

  • Recipients of a multi-organ transplant.
  • Recipients of a transplant from a cadaveric donor with a cold ischemic time \> 30 hours.
  • Breast-feeding, pregnant, or fertile women who do not use a reliable anticonceptive method before starting therapy with the study drug, during the therapy, and during the 4 months after the last dose of the drugs administered in the study.
  • Patients with active hepatic illness evidence.
  • Patients with active peptic ulcer.
  • Patients with serious diarrhoea or any intestinal upset that may interfere in the absorption capability of oral medication, including diabetic patients with previously diagnosticated diabetic gastroenteropathy.
  • Patients with evidence of active systemic infection that require the continued use of antibiotics or evidence of HIV infection or hepatitis B presence (positive HBs-Ag) or active chronic hepatitis C.
  • Patients with malignancy history (except satisfactorily treated non- melanocytic localized skin cancer and cervix "in situ" carcinoma).
  • Patients with history of psychologic disease that may interfere in the patients capability to understand the study requirements.
  • Patients who the investigator thinks need a treatment with any medication listed below:
  • Azathioprine,
  • Methotrexate,
  • Cyclofosfamide,
  • Polyclonal or monoclonal anti-lymphocitaries antibodies (OKT3, ATG), used for the induction in patients with high immunologic risk,
  • Basiliximab, and
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, La Coruña, 15706, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, 28007, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Madrid, 28034, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Madrid, 28041, Spain

Location

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38320, Spain

Location

Hospital Universitario La Fe

Valencia, Valencia, 46009, Spain

Location

MeSH Terms

Conditions

Kidney DiseasesRejection, Psychology

Interventions

TacrolimusSirolimus

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Miguel A Gonzalez Molina, MD

    Sociedad Andaluza de Trasplantes de Organos y Tejidos

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 9, 2006

First Posted

February 10, 2006

Last Updated

May 15, 2007

Record last verified: 2006-02

Locations

ES(7)