Study of Everolimus in de Novo Renal Transplant Recipients
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Purpose
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.
| Condition | Intervention |
|---|---|
|
End Stage Renal Failure With Renal Transplant |
Drug: Everolimus |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- 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 ] [ Designated as safety issue: Yes ]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).
- graft acute rejection [ Time Frame: 6 and 12 months after conversion ] [ Designated as safety issue: Yes ]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;
- Laboratory results and clinical alterations [ Time Frame: 3, 6 and 12 months after conversion ] [ Designated as safety issue: Yes ]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
| Estimated Enrollment: | 70 |
| Study Start Date: | March 2013 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Control
35 patients using Cyclosporin or Tacrolimus (C0=100-200/5-10ng/mL)+ Myfortic® 1440mg/dia + Steroids. Medications will be administered orally, twice a day |
|
|
Active Comparator: Intervention
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. |
Drug: Everolimus
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. Other Name: Certican
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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)
- 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.
Contacts and Locations| Contact: Hélady S Pinheiro, MD, PhD | +55(32)9982 8439 | heladysanders@gmail.com |
| Contact: Maria S van Keulen, RN | +55(32) 8437 6754 | maria.keulen@hotmail.com |
| Brazil | |
| Hospital das Clínicas da Universidade Federal de Minas Gerais | Withdrawn |
| Belo Horizonte, MG, Brazil, 30130-100 | |
| Hospital São João de Deus/Fundação Geraldo Corrêa | Recruiting |
| Divinópolis, MG, Brazil, 35500-227 | |
| Contact: Vânia C Ferreira, MD +55(37)99861461 vaniacrisfer@uol.com.br | |
| Principal Investigator: Vânia C Ferreira, MD | |
| Hospital Márcio Cunha/Fundação São Francisco Xavier | Not yet recruiting |
| Ipatinga, MG, Brazil, 35160-158 | |
| Contact: Carlos C Calazans, MD +55(32)92396413 carlos.calazans@usiminas.com | |
| Principal Investigator: Carlos C Calazans, MD | |
| Fundação IMEPEN | Active, not recruiting |
| Juiz de Fora, MG, Brazil, 36036-330 | |
| Hospital do Rim de MOntes Claros/Irmandade Nossa Senhora das Mercês | Not yet recruiting |
| Montes Claros, MG, Brazil, 39400-103 | |
| Contact: Geraldo S Meira, MD +55(32)88220199 nefrologia@santacasamontesclaros.com.br | |
| Principal Investigator: Geraldo S Meira, MD | |
| Principal Investigator: | Hélady S Pinheiro, MD, PhD | Fundação IMEPEN |
More Information
No publications provided
| Responsible Party: | Helady S Pinheiro, MD, PhD, MD, PhD, Fundação Instituto Mineiro de Estudo Pesquisa Em Nefrologi |
| ClinicalTrials.gov Identifier: | NCT01609673 History of Changes |
| Other Study ID Numbers: | CRAD001ABR22T |
| Study First Received: | May 24, 2012 |
| Last Updated: | April 19, 2013 |
| Health Authority: | Brazil: Ethics Committee |
Keywords provided by Fundação Instituto Mineiro de Estudo Pesquisa Em Nefrologi:
|
Immunosuppression Chronic Kidney Disease Renal Transplant |
Additional relevant MeSH terms:
|
Kidney Failure, Chronic Renal Insufficiency Renal Insufficiency, Chronic Kidney Diseases Urologic Diseases Everolimus Sirolimus Immunosuppressive Agents Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 16, 2013