Kidney TransplantPhase 4NCT01455649
Study to Evaluate the Safety and Efficacy of Switching Calcineurin Inhibitor to Everolimus After Kidney Transplantation in Adults
A Phase 4 study testing Everolimus and calcineurin inhibitor in people with Kidney Transplant and Immunosuppression, run by Deise de Boni Monteiro de Carvalho at 1 site in Brazil.
Trial summary
The purpose of this study is to demonstrate the efficacy and safety in the use of everolimus, with its onset after 3 months of treatment with calcineurin inhibitor. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Transplant, Immunosuppression
- What is being tested?
- Everolimus and calcineurin inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2011to Nov 2013
- 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
- Patients aged from 18 to 65 years old
- First transplantation recipients
- PRA < 30%
- Living or cadaveric donor
- Stable renal function
- Patients not pregnant or breastfeeding , where pregnancy is defined as the woman status from conception to gestation conclusion, through a positive beta hCG test (>5mUI/mL)
- Provided written informed consent form
Who cannot join
- Cadaveric donor with expanded criterion
- Multiple organs transplantation
- Kidney cold ischemia time > 24 hours
- Severe rejection episode - Banf >IIA
- Glomerular filtration rate < 35mL/min
- Presence of hard to treat dyslipidemia - severe hypercholesterolemia (>350mg/dL) or hypertriglyceridemia (>500mg/dL)
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- Proteinuria > 800mg/24h
- Patients with history of malignancy of any organic system, treated or not, within 5 years, with or without evidence of local recurrence or metastases, other than localized basal cell carcinoma
- Female with childbearing potential without using a reliable contraceptive method.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital federal de Bonsucesso
Rio de Janeiro, Rio de Janeiro, 21041-030
About this study
Official title: A Prospective, Open-label, Controlled, Randomized Study to Evaluate the Safety and Efficacy of Switching Calcineurin Inhibitor to Everolimus After 90 to 150 Days After Kidney Transplantation in Adults, Maintaining Corticosteroid and Mycophenolate Sodium Compared to Patients Who Will Maintain the Use of Calcineurin Inhibitor
The purpose of this study is to demonstrate the efficacy and safety in the use of everolimus, with its onset after 3 months of treatment with calcineurin inhibitor.
Read the detailed description
The patient who met the inclusion and exclusion criteria will be included in the study and randomized into two groups in the third month post transplant, they will be in use of tacrolimus, corticosteroids and Mycophenolate sodium. The group 1 will undergo a conversion from calcineurin inhibitor to Everolimus within 1 day (overnight), group 2 will be maintained with the initial immunosuppression. We will start Everolimus at 1 mg 2x/day and three days after the beginning we will adjust the dose by the serum levels, which will be kept in 6 to 10ng/dL. The doses of corticosteroids and Mycophenolate sodium will be retained. There will be performed renal biopsies at randomization and after 12 months. The glomerular filtration rate will be calculated monthly using the MDRD.
- Conditions
- Kidney Transplant, Immunosuppression
- Being tested
- Everolimus, calcineurin inhibitor
- Keywords
- Kidney, Transplant, Immunosuppression, Everolimus, 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
Group will switch calcineurin inhibitor to everolimus within 1 day (overnight).
calcineurin inhibitorDrug
Also called Tacrolimus, Cyclosporin, NeoOral, Prograf
Group will maintain their initial immunosuppression therapy with calcineurin inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Everolimus | Experimental | Not described Receives: Drug: Everolimus |
| calcineurin inhibitor | Active comparator | Not described Receives: Drug: calcineurin inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Creatinine Clearance at 24 months
The primary objective is to demonstrate the effectiveness and non-inferiority of treatment with everolimus, by assessing renal function, in comparison with the use of calcineurin inhibitor.
Measured: baseline and two years
Secondary outcomes (1)
Number of Participants with Adverse Events
The secondary objective is to demonstrate the safety by comparing rejection episodes, graft loss, infection, cancer and death in the control group
Measured: baseline and two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionNov 2013 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deise de Boni Monteiro de Carvalho
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Deise de Boni Monteiro de Carvalho, Hospital Federal de Bonsucesso
- Investigators
- Francisco G Miloski, MD, Study chair, PhysicianTereza Matuck, MD, Study chair, Chief of the Nephrology DepartmentRegina Sousa, Study chair, Head Nurse of The Nephrology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01455649
- Sponsor's protocol ID
- CRAD001ABR17T
- Status last verified
- Oct 2011
- First submitted
- 11 Oct 2011
- Last updated
- 20 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Controlled, Randomized Study to Evaluate the Safety and Efficacy of Switching Calcineurin Inhibitor to Everolimus After 90 to 150 Days After Kidney Transplantation in Adults, Maintaining Corticosteroid and Mycophenolate Sodium Compared to Patients Who Will Maintain the Use of Calcineurin Inhibitor
- ClinicalTrials.gov ID
- NCT01455649
- Acronym / sponsor ID
- CRAD001ABR17T
- Conditions
- Kidney Transplant, Immunosuppression
- Keywords
- Kidney, Transplant, Immunosuppression, Everolimus, Graft function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Deise de Boni Monteiro de CarvalhoUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 20 Oct 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 purpose of this study is to demonstrate the efficacy and safety in the use of everolimus, with its onset after 3 months of treatment with calcineurin inhibitor.
Detailed description
The patient who met the inclusion and exclusion criteria will be included in the study and randomized into two groups in the third month post transplant, they will be in use of tacrolimus, corticosteroids and Mycophenolate sodium. The group 1 will undergo a conversion from calcineurin inhibitor to Everolimus within 1 day (overnight), group 2 will be maintained with the initial immunosuppression. We will start Everolimus at 1 mg 2x/day and three days after the beginning we will adjust the dose by the serum levels, which will be kept in 6 to 10ng/dL. The doses of corticosteroids and Mycophenolate sodium will be retained. There will be performed renal biopsies at randomization and after 12 months. The glomerular filtration rate will be calculated monthly using the MDRD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Everolimus | Experimental | Drug: Everolimus |
| calcineurin inhibitor | Active comparator | Drug: calcineurin inhibitor |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged from 18 to 65 years old
- First transplantation recipients
- PRA < 30%
- Living or cadaveric donor
- Stable renal function
Key exclusion criteria (9 listed)
- Cadaveric donor with expanded criterion
- Multiple organs transplantation
- Kidney cold ischemia time > 24 hours
- Severe rejection episode - Banf >IIA
- Glomerular filtration rate < 35mL/min
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: CerticanGroup will switch calcineurin inhibitor to everolimus within 1 day (overnight). | Drug | Everolimus |
| calcineurin inhibitorAlso: Tacrolimus, Cyclosporin, NeoOral, PrografGroup will maintain their initial immunosuppression therapy with calcineurin inhibitor | Drug | calcineurin inhibitor |
Primary outcome
Change from Baseline in Creatinine Clearance at 24 months
Time frame: baseline and two years
The primary objective is to demonstrate the effectiveness and non-inferiority of treatment with everolimus, by assessing renal function, in comparison with the use of calcineurin inhibitor.
1 secondary outcome
Number of Participants with Adverse Events
Time frame: baseline and two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 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.
Francisco G Miloski, MD study chair
Physician
Tereza Matuck, MD study chair
Chief of the Nephrology Department
Regina Sousa study chair
Head Nurse of The Nephrology Department
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 Everolimus and calcineurin inhibitor in people with Kidney Transplant and Immunosuppression, run by Deise de Boni Monteiro de Carvalho 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 7 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 20 Oct 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.
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 Deise BM Carvalho, MD (+55 (21) 99876059, deisebmc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Creatinine Clearance at 24 months (time frame: baseline and two years). 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 20 Oct 2011.