NCT00828503

Brief Summary

A prospective, randomized safety and efficacy study of Certican® as add-on therapy against CMV disease in renal transplant recipients OBJECTIVES: Primary Objective: To demonstrate efficacy of Certican® as add-on therapy against CMV disease in comparison to either valcyte® (valganciclovir) or cymevene® (ganciclovir) alone, evaluated by quantitative measurement of CMV-DNA with PCR from the blood (qCMV-PCR) Secondary Objectives: To assess safety and tolerability of Certican® in patients with CMV- disease To study the effects of Certican® treatment on quality of life

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2008

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 26, 2009

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

September 3, 2012

Status Verified

August 1, 2012

Enrollment Period

5 years

First QC Date

January 23, 2009

Last Update Submit

August 30, 2012

Conditions

Cytomegalovirus Disease

Keywords

Certi-CMVimmunosuppressive switch (to Certican)renal transplant

Outcome Measures

Primary Outcomes (1)

  • relative changes in CMV-load (copies/mL), as determined by qCMV-PCR from whole blood throughout the observational period

    2 years

Secondary Outcomes (1)

  • CMV-load (copies/mL) after 1-8 weeks, in months 3, 4, 6 and 12; Time (in weeks) until the CMV-load reaches ≤600 copies/mL

    2 years

Study Arms (2)

1 Certican + Valganciclovir

ACTIVE COMPARATOR

Valganciclovir will be administered and Certican (everolimus) will be added as immunosuppression

Drug: Certican (everolimus) + valganciclovir

2 Valganciclovir alone

ACTIVE COMPARATOR

Valganciclovir will be added alone.

Drug: Valganciclovir

Interventions

Certican (everolimus) + valganciclovirDRUG

Oral MED 1: Certican® initial dose: 1,5-3 mg day target trough level: 3-8 ng/mL (first levels will be performed after 3 days and then adjusted until - according to the judgement of the clinical investigator - a stable degree of immunosuppression is reached; thereafter Certican® trough levels will be performed at the scheduled appointments) MED 2: Valganciclovir (or ganciclovir) will be administered in addition to Certican (valganciclovir: 450 mg twice daily, ganciclovir 5 mg/kg i.v. twice daily)

1 Certican + Valganciclovir
ValganciclovirDRUG

Valganciclovir (or ganciclovir) will be administered alone (valganciclovir: 450 mg twice daily, ganciclovir 5 mg/kg i.v. twice daily)

2 Valganciclovir alone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CMV-disease after renal transplantation, i.e.,(1.) CMV present in the blood, and (2.) one of the following symptoms (for viral syndrome, from the American Society of Transplantation recommendations for use in clinical trials1):
  • body temperature ≥ 38°C
  • new or increased significant malaise
  • leucopenia (\< 3500/mL)
  • atypical lymphocytosis ≥ 5%
  • thrombocytopenia (platelets \< 100.000/mL)
  • no other cause of symptoms/signs identified
  • informed consent of the patient

You may not qualify if:

  • patients with a known hypersensitivity to everolimus, sirolimus or any of the excipients
  • administration of strong CYP3A4 Inhibitors (e.g. ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin) and inducers (rifampicin), unless the benefit outweighs the risk, according to the judgment of the clinical investigator
  • acute rejection episodes in the first 3 months after renal transplantation
  • active hepatitis in the previous month
  • Significant proteinuria (\> 0.8g/24h Urine)
  • hepatic impairment, according to the criteria defined by Bénichou et al.2: a singular elevation of GPT or conjugated bilirubin to a value twice above the normal level, or a combined elevation of GOT, AP, and total bilirubin, given that at least one parameter is twice above the normal level
  • hematocrit \< 25%
  • any significant wound healing disorder (anamnestic)
  • blood white blood cell (WBC) count \< 3000/mL
  • platelets \< 50.000/mL
  • severe dyslipidemia (cholesterol \>300mg/dL, triglycerides \> 350mg/dL)
  • uncontrolled hypertension (continuous episodes of hypertension above 140/90 (WHO classification and American Society of Transplantation recommendations 3) despite adequate hypertensive therapy)
  • uncontrolled hyperuricemia (uric acid \> 8mg/dL)
  • pregnancy
  • any immunosuppressive protocol which does not allow the addition of Certican®, according to the judgment of the clinical investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, Austria, 1090, Austria

RECRUITING

Related Publications (3)

  • Humar A, Michaels M; AST ID Working Group on Infectious Disease Monitoring. American Society of Transplantation recommendations for screening, monitoring and reporting of infectious complications in immunosuppression trials in recipients of organ transplantation. Am J Transplant. 2006 Feb;6(2):262-74. doi: 10.1111/j.1600-6143.2005.01207.x.

    PMID: 16426310BACKGROUND

  • Benichou C. Criteria of drug-induced liver disorders. Report of an international consensus meeting. J Hepatol. 1990 Sep;11(2):272-6. doi: 10.1016/0168-8278(90)90124-a.

    PMID: 2254635BACKGROUND

  • Kasiske BL, Vazquez MA, Harmon WE, Brown RS, Danovitch GM, Gaston RS, Roth D, Scandling JD, Singer GG. Recommendations for the outpatient surveillance of renal transplant recipients. American Society of Transplantation. J Am Soc Nephrol. 2000 Oct;11 Suppl 15:S1-86.

    PMID: 11044969BACKGROUND

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

EverolimusValganciclovir

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic ChemicalsGanciclovirAcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Sabine Schmaldienst, MD

    Medical University of Vienna

    STUDY CHAIR

Central Study Contacts

Marcus D Säemann, MD

CONTACT

+431404005593marcus.saemann@meduniwien.ac.at

Manfred Hecking, MD

CONTACT

+431404005593manfred.hecking@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ass. Prof. Dr. Marcus Säemann

Study Record Dates

First Submitted

January 23, 2009

First Posted

January 26, 2009

Study Start

December 1, 2008

Primary Completion

December 1, 2013

Study Completion

June 1, 2014

Last Updated

September 3, 2012

Record last verified: 2012-08

Locations

AU(1)