Disorder of Transplanted KidneyNCT01353053
Comparison of Two Immunosuppressive Regimens in Kidney Transplant Recipients With Deceased Donors With the Aim of Preventing the Development of Fibrosis / Atrophy of Reducing the Incidence of Cytomegalovirus Infection
An observational study of Disorder of Transplanted Kidney and Cytomegalovirus Infections, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The aim of this the study is to the assess whether the graft and patient survival, rejection rates and renal graft function after the first year will not differ between both study arms. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Disorder of Transplanted Kidney, Cytomegalovirus Infections
- How many people
- 82 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2010to not given
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A randomized study of 82 patients transplanted in first transplant recipients of deceased donor and in line for kidney transplantation.
Who may be able to join
- Patients with BMI below 30,
- first transplants with PRA < 30,
- no contraindication for induction Thymoglobuline,
- age 18 years or younger than 70 years.
Who cannot join
- patients with a BMI above 30
- retransplantation
- patients hypersensitized with PRA > 30
- compared with Thymoglobulina indication for induction
- age under 18 or over 70 years
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Israelita Albert Einstein
São Paulo, São Paulo
Lucio Requião Moura, 55-11, lrequiao@nefro.epm.br
Alvaro Pacheco-Silva, Doctor
About this study
The aim of this the study is to the assess whether the graft and patient survival, rejection rates and renal graft function after the first year will not differ between both study arms. The investigators will also the evaluate the reduction in the incidence of cytomegalovirus the and improvement of renal function of the everolimus after 1 year.
- Keywords
- Immunosuppression, Cytomegalovirus, Renal Transplant, Atrophy/interstitial, Conversion of tacrolimus everolimus
- Medical subject headings
- Cytomegalovirus Infections, Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus, Everolimus | Immunosuppression is the same for all patients in the study until the period between the 3rd and 5th weeks, when patients will be randomized to initial regimen and remain or be converted to everolimus tacrolimus. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2011 (estimated)
- Study startJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of Transplanted KidneyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353053
- Sponsor's protocol ID
- 056410
- Status last verified
- May 2010
- First submitted
- 11 May 2011
- Last updated
- 12 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Immunosuppressive Regimens in Kidney Transplant Recipients With Deceased Donors With the Aim of Preventing the Development of Fibrosis / Atrophy of Reducing the Incidence of Cytomegalovirus Infection
- ClinicalTrials.gov ID
- NCT01353053
- Acronym / sponsor ID
- 056410
- Keywords
- Immunosuppression, Cytomegalovirus, Renal Transplant, Atrophy/interstitial, Conversion of tacrolimus everolimus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Jul 2010
- First posted
- 12 May 2011 (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 aim of this the study is to the assess whether the graft and patient survival, rejection rates and renal graft function after the first year will not differ between both study arms. The investigators will also the evaluate the reduction in the incidence of cytomegalovirus the and improvement of renal function of the everolimus after 1 year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus, Everolimus | – | –Immunosuppression is the same for all patients in the study until the period between the 3rd and 5th weeks, when patients will be randomized to initial regimen and remain or be converted to everolimus tacrolimus. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A randomized study of 82 patients transplanted in first transplant recipients of deceased donor and in line for kidney transplantation.
Key inclusion criteria (4 listed)
- Patients with BMI below 30,
- first transplants with PRA < 30,
- no contraindication for induction Thymoglobuline,
- age 18 years or younger than 70 years.
Key exclusion criteria (5 listed)
- patients with a BMI above 30
- retransplantation
- patients hypersensitized with PRA > 30
- compared with Thymoglobulina indication for induction
- age under 18 or over 70 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disorder of Transplanted Kidney and Cytomegalovirus Infections, run by Federal University of São Paulo 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 5 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 12 May 2011. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
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 12 May 2011.