Conversion to Sirolimus: Effects in Cytomegalovirus Infection Recurrence

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This protocol is a prospective, randomized, single center, designed to evaluate incidence of cytomegalovirus recurrence infection/disease in two immunosuppressive regimens, after the first episode of cytomegalovirus: (1) conversion of azathioprine or mycophenolate to sirolimus, in a regimen wih low doses tacrolimus and prednisone; ( 2) Maintenance of the current regimen during the first episode of cytomegalovirus infection ( azathioprine or mycophenolate, in combination to tacrolimus or prednisone). Our hypothesis is that conversion from azathioprine or sodium mycophenolate to sirolimus, with low doses of tacrolimus, and prednisone results in lower recurrence of cytomegalovirus infection/disease in kidney transplant recipients. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02671318
Study type	Interventional
Source	Hospital do Rim e Hipertensão
Contact	Geovana Basso, MD
Phone	+55 11 50878000
Email	geovana_basso@hotmail.com
Status	Recruiting
Phase	Phase 4
Start date	September 2015
Completion date	August 2020

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT03950414` - A Dose-Escalation Study Evaluating Safety and Tolerability of Viral-Specific T Cells Against CMV in Adult Solid Organ Transplant Recipients	Phase 1
Recruiting	`NCT04690933` - AntiCMV molécules Monitoring in Real-life in Stem Cell Recipients
Withdrawn	`NCT04936971` - Introduction of mTor Inhibitors and the Activation of the Cytomegalovirus (CMV) -Specific Cellular Immune Response	Phase 4
Completed	`NCT01325636` - Injection of CD4 and CD8 + T Cells Anti-Cytomegalovirus (CMV) or Anti-adenovirus	Phase 1/Phase 2
Recruiting	`NCT00228202` - Genotyping of Cytomegalovirus From Patients in Israel	N/A
Completed	`NCT00031421` - Neonatal CMV-Ganciclovir Follow-up Study	N/A
Completed	`NCT00005496` - Inflammation, Infection, and Future Cardiovascular Risk	N/A
Terminated	`NCT03262194` - Relevance of Gastric Aspirate in HCMV Detection
Completed	`NCT04478474` - Cytomegalovirus (CMV) Viremia and Disease Occurrence in Pediatric Allogeneic Stem Cell Transplantation Recipients
Recruiting	`NCT05370976` - Efficacy and Safety of Cytotect®CP, Hyperimmune Anti-CMV IVIg as CMV Prophylaxis in Patients Developing Acute Grade II-IV GVHD After Allogeneic Hematopoietic Cell Transplantation.	Phase 2
Active, not recruiting	`NCT02943057` - Topical 2% Ganciclovir Eye Drop for CMV Anterior Uveitis / Endotheliitis	Phase 4
Completed	`NCT02538172` - Cell-mediated Immunity for Prevention of CMV Disease	N/A
Completed	`NCT02642822` - The Epidemiologic Study of Human Cytomegalovirus（CMV） in Female Students of Xiamen University	N/A
Completed	`NCT02134184` - The Influence of Chronic CMV Infection on Influenza Vaccine Responses	Phase 4
Completed	`NCT00673868` - Cytomegalovirus (CMV) Specific Cytotoxic T Lymphocytes (CTL) When Used for Prophylaxis Against CMV in Recipients of Allogeneic, T Cell Depleted Stem Cell Transplants	Phase 1
Active, not recruiting	`NCT05089630` - A Study of Safety and Immune Response to Different Doses of a Cytomegalovirus Vaccine in Healthy Adults	Phase 1/Phase 2
Not yet recruiting	`NCT06058858` - Incidence and Risks Factors of CMV Reactivation in Patients Receiving of CAR-T Cells for Acute Leukemia and Lymphoma Relapse, a Cohort Study Analysis
Active, not recruiting	`NCT04904614` - Letermovir Use in Heart Transplant Recipients	Phase 4
Completed	`NCT01986010` - Safety, Tolerability, and Immunogenicity of the Human Cytomegalovirus Vaccine (V160) in Healthy Adults (V160-001)	Phase 1
Recruiting	`NCT06145178` - A Study of Human Cytomegalovirus (HCMV) Vaccine SPYVLP01 With and Without Adjuvants	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Conversion to Sirolimus: Effects in Cytomegalovirus Infection Recurrence — StopCMV

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms