Delayed Function of Renal TransplantPhase 4NCT01663805
Effects of the Use of "de Novo" Everolimus in Renal Tranplant Population
A Phase 4 study testing Everolimus in people with Delayed Function of Renal Transplant, run by MARIO ABBUD FILHO at 3 sites in Brazil.
Trial summary
This is an open, randomized, single-center study. The selected patients will be first divided into two major groups according to the type of organ to be transplanted: standard criteria donor (SCD) or extended criteria (ECD) kidney. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Delayed Function of Renal Transplant
- What is being tested?
- Everolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesBrazil
- Study dates
- Jan 2012to Jun 2015
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years (black and white subjects);
- End-stage renal disease with indication for transplantation (primary deceased-donor kidney transplant)
- "Standard" traditional (SCD) or extended criteria (ECD) donor;
- Informed consent form duly signed before SCD or ECD kidney transplantation.
Who cannot join
- The subject, in the opinion of the investigator, is not able to complete the study protocol;
- Recipient of live-donor kidney graft;
- Multiple organ transplant recipient;
- Evidence of large systemic or localized infection;
- Evidence of infiltration, cavitation or consolidation on chest X-rays obtained during the evaluation in the screening / baseline visit;
- Use of any drug under investigation or treatment until up to 4 weeks before transplantation;
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- Known or suspected hypersensitivity to tacrolimus, everolimus or mycophenolate sodium;
- Immunosuppressive therapies in addition to those described for this study;
- Hypersensitized patients (PRA > 30%);
- Patients with HIV+ or Hepatitis B or C virus infection.
- Patients for whom T0 and T15 biopsies were not taken.
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites, 3 recruiting
- Recruiting
Instituto de Urologia e Nefrologia
São José do Rio Preto, São Paulo, 15015-200
Mario Abbud, MD.PhD, 551740099191, mabbud@terra.com.br
Amanda Calori, 551740099167, estudos@iun.com.br
- Recruiting
Instituto de Urologia e Nefrologia
São José do Rio Preto, São Paulo, 15015-200
Mario Abbud, MD,Phd, 551740099191, mabbud@terra.com.br
Amanda Calori, 551740099191, estudos@iun.com.br
- Recruiting
Instituto de Urologia e Nefrologia
São José do Rio Preto, São Paulo, 15015200
Mario Abbud, MD,Phd, 551740099191, mabbud@terra.com.br
Amanda Calori, 551740099167, estudos@iun.com.br
About this study
Official title: Effects of the Use of "de Novo" Everolimus for the Expression of Cytokines in Kidneys From Extended Criteria Donors and With Delayed Graft Function
This is an open, randomized, single-center study. The selected patients will be first divided into two major groups according to the type of organ to be transplanted: standard criteria donor (SCD) or extended criteria (ECD) kidney. Then, each group will be randomly allocated to one of the treatments: tacrolimus (TAC) or everolimus (EVL).
All patients received induction therapy with basiliximab (BXB) and maintenance with Mycophenolate Sodium (MYF) and prednisone (P). This study will evaluate as Primary objectives: To characterize the molecular profile of cytokines in kidneys obtained from deceased donors such as "standard" (SCD) and extended criteria (ECD) in biopsies taken before and after transplantation and to evaluate the effect of treatment with everolimus (EVL) in the expression of these molecules. And as Secondaries objectives: To correlate the pattern of cytokines with delayed graft function (DGF), cold ischemia time, episodes of acute rejection and patient and graft survival.
Read the detailed description
A total of 80 patients will participate in the study, being distributed into 4 groups of 20 individuals. In a pilot study to assess the interventional effect of the mmediate use of EVL on the cytokine profile of ECD and SCD kidneys, compared to conventional immunosuppressive therapy with TAC, no statistical power analysis could be performed a priori.
Definitions of Extended Criteria Donor and Delayed Graft Function (DGF) Deceased donors aged ≥ 60 years or aged between 50 and 59 years and with at least two of the following risk factors: history of systemic hypertension terminal creatinine levels > 1.5 mg/dL or death by a cerebrovascular accident.
DGF (delayed graft function) is defined as the need for dialysis in the first 7 days after transplantation.
- Conditions
- Delayed Function of Renal Transplant
- Being tested
- Everolimus
- Keywords
- Extended Criteria Donor, Delayed Graft Function, DGF, Deceased donors aged ≥ 60 years, aged between 50 and 59 years, history of systemic hypertension, terminal creatinine levels > 1.5 mg/dL, death by a cerebrovascular accident
- Medical subject headings
- Delayed Graft Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
Also called Certican
Everolimus is started immediately after transplantation, the dosage of 1.5 mg twice a day, adjusted to achieve and maintain the blood level of 3-8 ng/mL.
| Study group | Role | What they receive |
|---|---|---|
| Everolimus | Active comparator | SCD/ECD: BXB (2x20mg, D1 and D4) + EVL (3.0 -8.0ng/ml) + MYF (1440mg/d)+ Prednisone Receives: Drug: Everolimus |
| mycophenolate sodium | No intervention | SCD/ECD: BXB (2x20mg, D1 and D4) + TAC + MYF (1440mg/d)+ Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular profile of cytokines
To characterize the molecular profile of cytokines in kidneys obtained from deceased donors such as "standard" (SCD) and extended criteria (ECD) in biopsies taken before and after transplantation and to evaluate the effect of treatment with everolimus (EVL) in the expression of these molecules.
Measured: 12 months
Secondary outcomes (1)
Pattern of cytokines with DGF, cold ischemia time, episodes of acute rejection
To correlate the pattern of cytokines with DGF, cold ischemia time, episodes of acute rejection and patient and graft survival
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2014 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Function of Renal TransplantStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MARIO ABBUD FILHO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, MARIO ABBUD FILHO, Instituto de Urologia e Nefrologia
- Investigators
- Mario Abbud, MD.PhD, Principal investigator, Instituto de Urologia e Nefrologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01663805
- Sponsor's protocol ID
- CRAD001ABR21T
- Status last verified
- Apr 2012
- First submitted
- 12 Apr 2012
- Last updated
- 13 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Use of "de Novo" Everolimus for the Expression of Cytokines in Kidneys From Extended Criteria Donors and With Delayed Graft Function
- ClinicalTrials.gov ID
- NCT01663805
- Acronym / sponsor ID
- CRAD001ABR21T
- Conditions
- Delayed Function of Renal Transplant
- Keywords
- Extended Criteria Donor, Delayed Graft Function, DGF, Deceased donors aged ≥ 60 years, aged between 50 and 59 years, history of systemic hypertension, terminal creatinine levels > 1.5 mg/dL, death by a cerebrovascular accident
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- MARIO ABBUD FILHOUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 13 Aug 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.
This is an open, randomized, single-center study. The selected patients will be first divided into two major groups according to the type of organ to be transplanted: standard criteria donor (SCD) or extended criteria (ECD) kidney. Then, each group will be randomly allocated to one of the treatments: tacrolimus (TAC) or everolimus (EVL).
All patients received induction therapy with basiliximab (BXB) and maintenance with Mycophenolate Sodium (MYF) and prednisone (P). This study will evaluate as Primary objectives: To characterize the molecular profile of cytokines in kidneys obtained from deceased donors such as "standard" (SCD) and extended criteria (ECD) in biopsies taken before and after transplantation and to evaluate the effect of treatment with everolimus (EVL) in the expression of these molecules. And as Secondaries objectives: To correlate the pattern of cytokines with delayed graft function (DGF), cold ischemia time, episodes of acute rejection and patient and graft survival.
Detailed description
A total of 80 patients will participate in the study, being distributed into 4 groups of 20 individuals. In a pilot study to assess the interventional effect of the mmediate use of EVL on the cytokine profile of ECD and SCD kidneys, compared to conventional immunosuppressive therapy with TAC, no statistical power analysis could be performed a priori.
Definitions of Extended Criteria Donor and Delayed Graft Function (DGF) Deceased donors aged ≥ 60 years or aged between 50 and 59 years and with at least two of the following risk factors: history of systemic hypertension terminal creatinine levels > 1.5 mg/dL or death by a cerebrovascular accident.
DGF (delayed graft function) is defined as the need for dialysis in the first 7 days after transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Everolimus | Active comparator | Drug: EverolimusSCD/ECD: BXB (2x20mg, D1 and D4) + EVL (3.0 -8.0ng/ml) + MYF (1440mg/d)+ Prednisone |
| mycophenolate sodium | No intervention | –SCD/ECD: BXB (2x20mg, D1 and D4) + TAC + MYF (1440mg/d)+ Prednisone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years (black and white subjects);
- End-stage renal disease with indication for transplantation (primary deceased-donor kidney transplant)
- "Standard" traditional (SCD) or extended criteria (ECD) donor;
- Informed consent form duly signed before SCD or ECD kidney transplantation.
Key exclusion criteria (11 listed)
- The subject, in the opinion of the investigator, is not able to complete the study protocol;
- Recipient of live-donor kidney graft;
- Multiple organ transplant recipient;
- Evidence of large systemic or localized infection;
- Evidence of infiltration, cavitation or consolidation on chest X-rays obtained during the evaluation in the screening / baseline visit;
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 |
|---|---|---|
| EverolimusAlso: CerticanEverolimus is started immediately after transplantation, the dosage of 1.5 mg twice a day, adjusted to achieve and maintain the blood level of 3-8 ng/mL. | Drug | Everolimus |
Primary outcome
Molecular profile of cytokines
Time frame: 12 months
To characterize the molecular profile of cytokines in kidneys obtained from deceased donors such as "standard" (SCD) and extended criteria (ECD) in biopsies taken before and after transplantation and to evaluate the effect of treatment with everolimus (EVL) in the expression of these molecules.
1 secondary outcome
Pattern of cytokines with DGF, cold ischemia time, episodes of acute rejection
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 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.
Mario Abbud, MD.PhD principal investigator
Instituto de Urologia e Nefrologia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Everolimus in people with Delayed Function of Renal Transplant, run by MARIO ABBUD FILHO at 3 sites 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 11 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 13 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Mario Abbud, MD.PhD (551740099191, mabbud@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular profile of cytokines (time frame: 12 months). 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 13 Aug 2012.