CMV seronegative patients that have received kidney allografts from CMV seropositive donors
Conditions
Interventions
Clinical safety/efficacy, nonrandomized, open-label, single-arm, phase 2a. It will be included 20 patients of both sexes aged between 18 and 65 years. Patients will receive 6 doses of 15 mg/kg of the
Drug
Biological/vaccine
Sponsors
Theraclone Sciences, Inc
Worldwide Clinical Research Monitoramento de Pesquisas Clínicas do Brasil Ltda
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patients who are males or females aged 18 to 65 years, inclusive;Patients who are single-organ recipients (kidney only) and CMV seronegative and receiving a kidney transplant from a CMV seropositive (cadaver or living) donor;Females must not be pregnant or nursing and must either be of non-childbearing potential or must agree to use 2 acceptable methods of birth control and must agree to continue doing so for four months after the last dose of TCN-202;Females of childbearing potential and males with female partners with childbearing potential must agree to use effective contraception and must agree to continue doing so for four months after TCN-202 dosing;Adequate venous access and able to receive intravenous infusion;Patients must be able to understand the purpose and risks of the study and sign the informed consent form (ICF).
Exclusion criteria
Exclusion criteria: Patients who require anti-lymphocyte preparations for induction therapy (indication in the rejection of transplanted organs) or those who receive a kidney with a cold ischemia time higher than 30 hours;patients presenting any acute medical condition or significant past medical history or any condition that in the opinion of the Principal Investigator (PI) or the Sponsor would complicate or compromise the study, or the well-being of the patient;Patients with known positivity to Hepatitis B, Hepatitis C and HIV (1 and 2);Patients with history of cancer (except for non-melanoma skin cancer) within 2 years prior to transplantation;patients with history of drug or alcohol abuse within 6 months prior to transplantation;patients who have received an investigational product in any clinical trial within 12 months of transplantation;patients who have received prior treatment with a monoclonal antibody;Patients who require concomitant treatment with other investigational drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients treated with TCN-202 who develop CMV infection during the first 3 months posttransplant;The incidence and severiry of adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| The viral load of the CMV detected by PCR deemed clinically relevant that results in initiation of antiviral treatment;The proportion of patients treated with TCN-202 who develop CMV infection or CMV disease during the first 12 months posttransplant;The proportion of patients treated with TCN-202 who require antiviral therapy during the first 12 months posttransplant;The proportion of patients treated with TCN-202 who develop CMV resistance to ganciclovir during the first 12 months posttransplant;The proportion of patients treated with TCN-202 who develop biopsy-proven rejection at 6 and 12 months posttransplant;The survival of the patients and of the grafts at 12 months posttransplant;The proportion of patients who develop mutations in the DNA of the CMV;The proportion of patients treated with TCN-202 who develop antibodies to TCN-202;The proportion of patients treated with TCN-202 who develop CMV-specific immunity;The proportion of patients treated with TCN-202 who have sufficient data are available for the determination of pharmacokinetic parameters. | — |
Countries
Brazil
Contacts
Public ContactDaniela;Sandra Santos;Schefler
Clinipace Pesquisas Clínicas do Brasil Ltda. - CPWW;Clinipace Pesquisas Clínicas do Brasil Ltda. - CPWW
Outcome results
None listed