Kidney Transplant RecipientsPhase 4NCT01608412
A Clinical Trial to Assess the Efficacy and Safety of the Conversion to Everolimus
A Phase 4 study testing Tacrolimus and Everolimus in people with Kidney Transplant Recipients, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Recipients
- What is being tested?
- Tacrolimus and Everolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2012to Jul 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Luiz Felipe S. Gonçalves, MD contact
Nisséia Jahn, RN contact
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: An Open-label Randomized Controlled Clinical Trial to Assess the Efficacy and Safety of the Conversion to Everolimus 3 Months After Kidney Transplantation.
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.
- Conditions
- Kidney Transplant Recipients
- Being tested
- Tacrolimus, Everolimus
- Keywords
- renal transplantation, everolimus, tacrolimus, molecular evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
TACROLIMUS (C0 = 5-10 ng/mL) + MPS 1440 mg + Pred
EverolimusDrug
Everolimus (C0 = 6-10 ng/mL) + MPS 1440 mg + Pred
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus | Active comparator | 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 Receives: Drug: Tacrolimus |
| Everolimus | Active comparator | 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 Receives: Drug: Everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate cumulative patient and graft survival at 12 months post conversion
Patient and graft survival will be evaluated one year after randomization by Kaplan-Meier analysis
Measured: one year
Secondary outcomes (1)
Evaluation of estimated glomerular filtration rate 12 months post-conversion
- To assess the efficacy of conversion from tacrolimus to everolimus 12 months post-conversion by measuring the estimated glomerular filtration rate using the Modification of Diet in Renal Disease (MDRD) equation
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startFeb 2012
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant RecipientsStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luiz Felipe S. Gonçalves, MD, Principal investigator, HCPA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608412
- Sponsor's protocol ID
- CRAD001ABR19T
- Status last verified
- Aug 2011
- First submitted
- 8 May 2012
- Last updated
- 31 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Randomized Controlled Clinical Trial to Assess the Efficacy and Safety of the Conversion to Everolimus 3 Months After Kidney Transplantation.
- ClinicalTrials.gov ID
- NCT01608412
- Acronym / sponsor ID
- CRAD001ABR19T
- Conditions
- Kidney Transplant Recipients
- Keywords
- renal transplantation, everolimus, tacrolimus, molecular evaluation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 31 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus | Active comparator | Drug: TacrolimusThe 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 |
| Everolimus | Active comparator | Drug: EverolimusThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TacrolimusTACROLIMUS (C0 = 5-10 ng/mL) + MPS 1440 mg + Pred | Drug | Tacrolimus |
| EverolimusEverolimus (C0 = 6-10 ng/mL) + MPS 1440 mg + Pred | Drug | Everolimus |
Primary outcome
Evaluate cumulative patient and graft survival at 12 months post conversion
Time frame: one year
Patient and graft survival will be evaluated one year after randomization by Kaplan-Meier analysis
1 secondary outcome
Evaluation of estimated glomerular filtration rate 12 months post-conversion
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luiz Felipe S. Gonçalves, MD contact
Nisséia Jahn, RN contact
Luiz Felipe S. Gonçalves, MD principal investigator
HCPA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tacrolimus and Everolimus in people with Kidney Transplant Recipients, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luiz Felipe S. Gonçalves, MD (lfgoncalves@hcpa.ufrgs.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate cumulative patient and graft survival at 12 months post conversion (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2012.