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Study of Everolimus in de Novo Renal Transplant Recipients

This study has been terminated.
(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.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01609673
First Posted: June 1, 2012
Last Update Posted: June 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis
Information provided by (Responsible Party):
Helady Pinheiro, MD, PhD, Fundação Instituto Mineiro de Estudo Pesquisa Em Nefrologi
  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
Intervention Model: Parallel Assignment
Masking: None (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

Resource links provided by NLM:


Further study details as provided by Helady Pinheiro, MD, PhD, Fundação Instituto Mineiro de Estudo Pesquisa Em Nefrologi:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • graft acute rejection [ Time Frame: 6 and 12 months after conversion ]
    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 ]
    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


Enrollment: 1
Study Start Date: March 2013
Study Completion Date: May 2013
Primary Completion Date: May 2013 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01609673


Locations
Brazil
Hospital São João de Deus/Fundação Geraldo Corrêa
Divinópolis, MG, Brazil, 35500-227
Hospital Márcio Cunha/Fundação São Francisco Xavier
Ipatinga, MG, Brazil, 35160-158
Fundação IMEPEN
Juiz de Fora, MG, Brazil, 36036-330
Hospital do Rim de MOntes Claros/Irmandade Nossa Senhora das Mercês
Montes Claros, MG, Brazil, 39400-103
Sponsors and Collaborators
Helady Pinheiro, MD, PhD
Novartis
Investigators
Principal Investigator: Hélady S Pinheiro, MD, PhD Fundação IMEPEN
  More Information

Responsible Party: Helady 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
First Submitted: May 24, 2012
First Posted: June 1, 2012
Last Update Posted: June 12, 2013
Last Verified: June 2013

Keywords provided by Helady Pinheiro, MD, PhD, Fundação Instituto Mineiro de Estudo Pesquisa Em Nefrologi:
Immunosuppression
Chronic Kidney Disease
Renal Transplant

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Everolimus
Sirolimus
Calcineurin Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action