MedDataX Logo

A Clinical Trial to Assess the Efficacy and Safety of the Conversion to Everolimus

NCT ID: NCT01608412

Last Updated: 2012-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study hypotheses to be tested in this study are:

* Conversion to everolimus at 3 months post-transplantation is safe and effective;
* Accurate noninvasive molecular diagnostic tests can replace biopsy at 3 months pre-conversion (for the diagnosis of subclinical cellular and/or humoral rejection, tissue fibrosis and calcineurin inhibitor-induced nephrotoxicity) in kidney transplant recipients;
* Follow-up biopsy at 12 months post-conversion (for the diagnosis of tissue fibrosis) can be replaced with accurate noninvasive molecular diagnostic tests in kidney transplant recipients.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Kidney Transplant Recipients

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

renal transplantation everolimus tacrolimus molecular evaluation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tacrolimus

The subjects included in the study will be clinically followed up for at least 12 months. The patients will be selected at 3 months post-transplant according to inclusion and exclusion criteria and randomized in a 1:1 ratio for conversion to everolimus or maintenance of tacrolimus therapy.

Intervention arm: Tacrolimus

Group Type ACTIVE_COMPARATOR

Tacrolimus

Intervention Type DRUG

TACROLIMUS (C0 = 5-10 ng/mL) + MPS 1440 mg + Pred

Everolimus

The subjects included in the study will be clinically followed up for at least 12 months. The patients will be selected at 3 months post-transplant according to inclusion and exclusion criteria and randomized in a 1:1 ratio for conversion to everolimus or maintenance of tacrolimus therapy.

Intervention arm: Everolimus

Group Type ACTIVE_COMPARATOR

Everolimus

Intervention Type DRUG

Everolimus (C0 = 6-10 ng/mL) + MPS 1440 mg + Pred

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tacrolimus

TACROLIMUS (C0 = 5-10 ng/mL) + MPS 1440 mg + Pred

Intervention Type DRUG

Everolimus

Everolimus (C0 = 6-10 ng/mL) + MPS 1440 mg + Pred

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients undergoing their first living- or deceased-donor kidney transplant who maintain a functioning graft 3 months post-transplant;
* Older than 18 years;
* Panel-reactive antibodies lower than 20%;
* Baseline immunosuppression with tacrolimus, mycophenolate sodium (MPS) and prednisone at randomization at 3 months.

Exclusion Criteria

* eGFR \< 35 mL/min at randomization;
* Urine protein-to-creatinine ratio \> 0.8 at randomization;
* Episode of acute rejection with Banff histological classification \> 1A in the first 3 months post-transplant;
* Cholesterol \> 350 mg/dL or triglycerides \> 400 mg/dL with therapy at randomization;
* Active infection at randomization;
* Chronic liver disease;
* Refusal to participate in the study;
* Contraindications to kidney biopsy;
* Biopsy findings at 3 months post-transplant including borderline rejection, cellular rejection or antibody-mediated rejection.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Luiz Felipe S. Gonçalves, MD

Role: PRINCIPAL_INVESTIGATOR

HCPA

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Luiz Felipe S. Gonçalves, MD

Role: CONTACT

Email: [email protected]

Nisséia Jahn, RN

Role: CONTACT

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CRAD001ABR19T

Identifier Type: -

Identifier Source: org_study_id