End Stage Renal Failure With Renal TransplantNCT01609673
Study of Everolimus in de Novo Renal Transplant Recipients
A study testing Everolimus in people with End Stage Renal Failure With Renal Transplant, run by Helady Pinheiro, MD, PhD at 4 sites in Brazil.
Trial summary
In the present study, the investigators propose a conversion scheme with 50% reduction in CNI dosage until adjustment of everolimus dosage, in order to reach a trough blood level of 6-10 ng/mL, thus avoiding overimmunosuppression or alternatively breakthrough rejection episodes. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- End Stage Renal Failure With Renal Transplant
- What is being tested?
- Everolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 4 sitesBrazil
- Study dates
- Mar 2013to May 2013
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Renal transplant patients
- Age between 18 and 85 years
- Recipients of living or deceased donors
- Donor under the age of 85 years
- Panel Reactivity Antibodies (PRA) over or equal to 30%
- 4-5 months post-transplant
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- CNI-based immunosuppressive regimen
- Stable graft function (creatinine lower than 2.0 mg/dl)
- No currently acute rejection
- Proteinuria lower than 800mg/d
- No laboratory or physical clinically significant signs presented for the last 2 months before screening.
Who cannot join
- Recipient of multiple organs
- Recipient with a history of focal segmental glomerulosclerosis or membranous glomerulonephritis
- Presence of uncontrolled hypercholesterolemia (≥350 mg/dL)hypertriglyceridemia (over or equal to 500 mg/dL)
- Patients with eGFR lower than 40 ml/min/1.73m2
- Evidence of acute rejection within 2 months before screening
- Thrombocytopenia (lower than 75,000/mm3)
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- Neutropenia (lower than 1,500/mm3)
- Leukocytopenia (lower than 2500/mm3)
- Anemia (hemoglobin lower than 6.0g/dL)
- Severe liver disease (including transaminases or bilirubin equal or over 3 times normal)
- Proteinuria over 800mg/dL
- Systemic infection or pneumonia (active infection)
- Positive for Hepatitis B, Hepatitis C or HIV.
Trial locations and contacts
4 sites in 1 country.
Brazil4 sites
Hospital São João de Deus/Fundação Geraldo Corrêa
Divinópolis, Minas Gerais, 35500-227
Hospital Márcio Cunha/Fundação São Francisco Xavier
Ipatinga, Minas Gerais, 35160-158
Fundação IMEPEN
Juiz de Fora, Minas Gerais, 36036-330
Hospital do Rim de MOntes Claros/Irmandade Nossa Senhora das Mercês
Montes Claros, Minas Gerais, 39400-103
About this study
Official title: Evaluation of the Early Conversion From a Calcineurin Inhibitor-based Immunosuppressive Regimen to Everolimus in de Novo Renal Transplant Recipients, a Multicenter Experience
In the present study, the investigators propose a conversion scheme with 50% reduction in CNI dosage until adjustment of everolimus dosage, in order to reach a trough blood level of 6-10 ng/mL, thus avoiding overimmunosuppression or alternatively breakthrough rejection episodes.
The hypothesis of this study is to demonstrate that the therapeutic regimen with Myfortic® and Certican® significantly improves renal function compared with the standard regimen of CNI.
- Being tested
- Everolimus
- Keywords
- Immunosuppression, Chronic Kidney Disease, Renal Transplant
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
Also called Certican
On the day of conversion (day 1), 2 mg everolimus will be introduced in the morning and at night, as morning dose of CsA or Tac will be maintained and evening dose of CsA or Tac will be reduced by 50%.
In two days, 2 mg everolimus will be associated with 50% of CsA or Tac original dosage, both in the morning and evening. After that, everolimus dose will be adjusted to achieve a C0 target level of 6-10 ng/mL. Once target levels of everolimus are met, the CNI drug will be suspended.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 35 patients using Cyclosporin or Tacrolimus (C0=100-200/5-10ng/mL)+ Myfortic® 1440mg/dia + Steroids. Medications will be administered orally, twice a day |
| Intervention | Active comparator | 35 randomized Patients Converted to Certican® (Everolimus C0=6-10 ng/mL) + Myfortic® 1440mg/day + Steroids.
On the day of conversion (day 1), 2 mg everolimus will be introduced in the morning and at night, as morning dose of CsA or Tac will be maintained and evening dose of CsA or Tac will be reduced by 50%.
In two days, 2 mg everolimus will be associated with 50% of CsA or Tac original dosage, both in the morning and evening. After that, everolimus dose will be adjusted to achieve a C0 target level of 6-10 ng/mL. Once target levels of everolimus are met, the CNI drug will be suspended. Receives: Drug: Everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in estimated glomerular filtration rate (eGFR)
The eGFR will be calculated by Cockcroft-Gault, CKD-EPI and MDRD equations, firstly 4-5 months after transplantation (baseline), and then 6 and 12 months after conversion to everolimus (Certican ®) and suspension of CNI, associated with Myfortic ® (mycophenolate sodium enteric-coated - MSEC).
Measured: 4-5 months after transplantation (baseline), and then 6 and 12 months after conversion to everolimus
Secondary outcomes (2)
graft acute rejection
incidence of acute biopsy-proven rejection and clinical acute rejection (without biopsy), graft loss, death with a functioning graft, and loss of follow up at 6 and 12 months after conversion;
Measured: 6 and 12 months after conversion
Laboratory results and clinical alterations
analyzing the incidence of anemia, thrombocytopenia, leukopenia, gastrointestinal side effects, pneumonitis, oral ulcers, edema, proteinuria, and any other adverse events, as well as the need of drug withdrawal
Measured: 3, 6 and 12 months after conversion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2012 (estimated)
- Study startMar 2013
- Primary completionMay 2013
- Study completionMay 2013
Why it stopped: The inclusion of proposed sample turned to be infeasible due to Ethical Non-approval of 2 research sites and another site no transplant activity since 2012.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Failure With 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helady Pinheiro, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor-investigator, Helady Pinheiro, MD, PhD, Fundação Instituto Mineiro de Estudo Pesquisa Em Nefrologi
- Investigators
- Hélady S Pinheiro, MD, PhD, Principal investigator, Fundação IMEPEN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01609673
- Sponsor's protocol ID
- CRAD001ABR22T
- Status last verified
- Jun 2013
- First submitted
- 24 May 2012
- Last updated
- 12 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Early Conversion From a Calcineurin Inhibitor-based Immunosuppressive Regimen to Everolimus in de Novo Renal Transplant Recipients, a Multicenter Experience
- ClinicalTrials.gov ID
- NCT01609673
- Acronym / sponsor ID
- CRAD001ABR22T
- Keywords
- Immunosuppression, Chronic Kidney Disease, Renal Transplant
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The inclusion of proposed sample turned to be infeasible due to Ethical Non-approval of 2 research sites and another site no transplant activity since 2012.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Helady Pinheiro, MD, PhDUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Mar 2013
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 1 Jun 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.
In the present study, the investigators propose a conversion scheme with 50% reduction in CNI dosage until adjustment of everolimus dosage, in order to reach a trough blood level of 6-10 ng/mL, thus avoiding overimmunosuppression or alternatively breakthrough rejection episodes.
The hypothesis of this study is to demonstrate that the therapeutic regimen with Myfortic® and Certican® significantly improves renal function compared with the standard regimen of CNI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –35 patients using Cyclosporin or Tacrolimus (C0=100-200/5-10ng/mL)+ Myfortic® 1440mg/dia + Steroids. Medications will be administered orally, twice a day |
| Intervention | Active comparator | Drug: Everolimus35 randomized Patients Converted to Certican® (Everolimus C0=6-10 ng/mL) + Myfortic® 1440mg/day + Steroids. On the day of conversion (day 1), 2 mg everolimus will be introduced in the morning and at night, as morning dose of CsA or Tac will be maintained and evening dose of CsA or Tac will be reduced by 50%. In two days, 2 mg everolimus will be associated with 50% of CsA or Tac original dosage, both in the morning and evening. After that, everolimus dose will be adjusted to achieve a C0 target level of 6-10 ng/mL. Once target levels of everolimus are met, the CNI drug will be suspended. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Renal transplant patients
- Age between 18 and 85 years
- Recipients of living or deceased donors
- Donor under the age of 85 years
- Panel Reactivity Antibodies (PRA) over or equal to 30%
Key exclusion criteria (13 listed)
- Recipient of multiple organs
- Recipient with a history of focal segmental glomerulosclerosis or membranous glomerulonephritis
- Presence of uncontrolled hypercholesterolemia (≥350 mg/dL)hypertriglyceridemia (over or equal to 500 mg/dL)
- Patients with eGFR lower than 40 ml/min/1.73m2
- Evidence of acute rejection within 2 months before screening
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: CerticanOn the day of conversion (day 1), 2 mg everolimus will be introduced in the morning and at night, as morning dose of CsA or Tac will be maintained and evening dose of CsA or Tac will be reduced by 50%. In two days, 2 mg everolimus will be associated with 50% of CsA or Tac original dosage, both in the morning and evening. After that, everolimus dose will be adjusted to achieve a C0 target level of 6-10 ng/mL. Once target levels of everolimus are met, the CNI drug will be suspended. | Drug | Intervention |
Primary outcome
Change in estimated glomerular filtration rate (eGFR)
Time frame: 4-5 months after transplantation (baseline), and then 6 and 12 months after conversion to everolimus
The eGFR will be calculated by Cockcroft-Gault, CKD-EPI and MDRD equations, firstly 4-5 months after transplantation (baseline), and then 6 and 12 months after conversion to everolimus (Certican ®) and suspension of CNI, associated with Myfortic ® (mycophenolate sodium enteric-coated - MSEC).
2 secondary outcomes
graft acute rejection
Time frame: 6 and 12 months after conversion
Laboratory results and clinical alterations
Time frame: 3, 6 and 12 months after conversion
Results and safety
The study was stopped early (reason given: The inclusion of proposed sample turned to be infeasible due to Ethical Non-approval of 2 research sites and another site no transplant activity since 2012.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2013.
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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.
Hélady S Pinheiro, MD, PhD principal investigator
Fundação IMEPEN
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Everolimus in people with End Stage Renal Failure With Renal Transplant, run by Helady Pinheiro, MD, PhD at 4 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 11 inclusion and 13 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: stopped early, as of the sponsor's last update on 12 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
Are results available for this study?
The study was stopped early (reason given: The inclusion of proposed sample turned to be infeasible due to Ethical Non-approval of 2 research sites and another site no transplant activity since 2012.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in estimated glomerular filtration rate (eGFR) (time frame: 4-5 months after transplantation (baseline), and then 6 and 12 months after conversion to everolimus). 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 12 Jun 2013.