Conversion to Sirolimus: Effects in Cytomegalovirus Infection Recurrence

NCT02671318 | Unknown Phase 4 DMC

• 1 other identifier: 43102815.0.0000.5505
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Cytomegalovirus is the most important opportunistic infection after kidney transplant, with increased in mortality, morbidity and higher costs of transplantation. Despite the favorable efficacy (lower acute rejection) results of the most worldwide used regime, tacrolimus, mycophenolate and prednisone, or the investigators local common regimen, tacrolimus, azathioprine and prednisone, this combinations are associated with higher incidence of cytomegalovirus infection, disease and recurrence. Namely, sirolimus use is associated with decreased risk of cytomegalovirus infection/disease, and there is not a prospective cohort to evaluate the conversion to sirolimus efficacy to decrease the cytomegalovirus infection recurrence. Given this, the investigators propose a study of their own initiative that attends local needs: evaluate the conversion to sirolimus efficacy in decrease the cytomegalovirus recurrence after kidney transplant.

Conditions

Cytomegalovirus Infections

Keywords

cytomegalovirus; sirolimus; cytomegalovirus recurrence; kidney transplant; conversion

Outcome Measures

Primary Outcomes (1)

• Cytomegalovirus infection/disease recurrence

  Cytomegalovirus infection/disease recurrence

  One year

Study Arms (2)

Drug conversion to sirolimus

ACTIVE COMPARATOR

Drug conversion to sirolimus: mycophenolate or azathioprine conversion to sirolimus, in a regimen with tacrolimus and prednisone.

Drug: Drug conversion to sirolimus

Maintenance of the current regimen

ACTIVE COMPARATOR

Maintenance of the current regimen: mycophenolate or azathioprine maintenance, in a regimen with tacrolimus and prednisone.

Drug: Maintenance of the current regimen

Interventions

Drug conversion to sirolimus DRUG

Drug conversion to sirolimus: mycophenolate or azathioprine conversion to sirolimus, in a regimen with tacrolimus and prednisone.

Also known as: Rapamune

Drug conversion to sirolimus

Maintenance of the current regimen DRUG

Maintenance of the current regimen: mycophenolate or azathioprine maintenance, in a regimen with tacrolimus and prednisone.

Also known as: Myfortic, Immuran

Maintenance of the current regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult kidney transplant recipients \> 18 y.o.
• Kidney Transplant recipients, after the first episode of cytomegalovirus infection, using the current immunosuppressive regimen: azathioprine or mycophenolate, tacrolimus and prednisone.

You may not qualify if:

• Re-transplant;
• Patients with any panel reactive antibody (PRA) equal to or above 50%, class I or class II;
• Acute rejection episode in the last 30 days, or episode \> 2A in the Banff criteria;
• GFR (MDRD) \< 40 ml/min;
• Proteinuria \> 0,5 g/l;
• Hemoglobin \< 10 g/l and/or leucocytes \< 4000 cels/mm3 and/or platelets \< 150.000 cels/mm3;
• Triglycerides \> 500 mg/dl with or without use of fibrate;
• Cholesterol total \> 300 mg/dl with or without use of statin;
• Hepatic abnormalities;
• Significant periphery edema;
• Pulmonary abnormalities or breast x-ray abnormalities;
• Hyper sensibility to sirolimus formula;

Sponsors & Collaborators

• Hospital do Rim e Hipertensão: lead

Study Sites (1)

Hospital do Rim

São Paulo, São Paulo, 04037-003, Brazil

RECRUITING

Related Publications (1)

• Viana LA, Cristelli MP, Basso G, Santos DW, Dantas MTC, Dreige YC, Requiao Moura LR, Nakamura MR, Medina-Pestana J, Tedesco-Silva H. Conversion to mTOR Inhibitor to Reduce the Incidence of Cytomegalovirus Recurrence in Kidney Transplant Recipients Receiving Preemptive Treatment: A Prospective, Randomized Trial. Transplantation. 2023 Aug 1;107(8):1835-1845. doi: 10.1097/TP.0000000000004559. Epub 2023 Jul 20.

  PMID: 37046380 DERIVED

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

Sirolimus; Mycophenolic Acid; Azathioprine

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids; Thionucleosides; Sulfur Compounds; Mercaptopurine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Geovana Basso, MD

  Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil

  PRINCIPAL INVESTIGATOR

• Helio Tedesco Silva Junior, PhD

  Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil

  STUDY CHAIR

• Claudia Rosso felipe, PhD

  Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil

  STUDY CHAIR

• Leonardo V. Riella, PhD

  Brigham and Women's Hospital, US.

  STUDY CHAIR

• Jose O. Medina Pestana, PhD

  Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil

  STUDY CHAIR

Central Study Contacts

Geovana Basso, MD

CONTACT

+55 11 50878000; geovana_basso@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 26, 2016
• First Posted: February 2, 2016
• Study Start: September 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: August 1, 2020
• Last Updated: August 17, 2016

Record last verified: 2016-08

Locations

BR (1)