After solid organ transplantation immunosuppressive treatment disrupts the individual balance between virus-replication and cellular immune response. This can lead to an elevated risk of severe viral complications. 1) Immunosuppressive therapy might better be steered by measuring of virus-specific T cells than by blood levels of immunosuppressants solely. 2) The antiviral treatment should be restricted to patients with high risk of viral diseases (high costs, severe side effects). MedDRA versio
Conditions
Interventions
Trade Name: Sandimmun Optoral 10 mg Weichkapseln
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: CICLOSPORIN
CAS Number: 59865-13-3
Other descriptive name: Cyclosporin A, Certican
Concentratio
Sponsors
Medizinische Hochschule Hannover
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who are males or non-pregnant females between the ages of 0 and 16 years. 2. Patients after kidney transplantation. 3. Patients who receive their first or second transplantation. 4. Patients who are single-organ recipients. 5. If patients are women of childbearing potential, they must have a negative serum pregnancy test with a sensitivity equal to at least 50 mIU/ml before transplantation. 6. If patients are women of childbearing potential, they must use an effective form of contraception like birth control pill (except mini pill), hormonal depot injection, contraceptive hormonal patches, implanon, contraceptive hormone containing coil or hormon containing contraceptive vaginal ring, unless abstinence is the chosen method. In case of medical contraindication concerning the hormonal contraception, an intrauterine coil with a second contraceptive method (sondom, diaphragm, spermicide) can be used. Effective contraception must be used before transplantation, during therapy and for 6 weeks following discontinuation og immunosuppressive therapy. 7. Patients’ guardians must be capable of understanding the purpose and risks of the study. 8. Patients whose guardians are willing to give written informed consent and willing to participate in and comply with the study protocol. Patients above 7 years have to agree with the study in addition to the informed consent of the legally authorized representative. Are the trial subjects under 18? yes Number of subjects for this age range: 64 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients participating in other studies or participated within the last four weeks. 2. Patients who are highly sensitized. 3. Patients who have previously undergone two organ transplantations. 4. Hypersensitivity to any of the components of the medication used. 5. Patients from other centers, who are not followed in the outpatient unit of the Hannover Medical School or corresponding recruiting centers. 6. Patients with a peak or current PRA of >50%. 7. Pregnant and/or lactating women and women of childbearing potential who are unwilling or unable to use contraception methods as specified. 8. Patients whose guardians do not understand the requirements of the study. 9. Patients with known positive HIV-1 or HCV test or the presence of HBsAg. 10. Patients with malignancies or history of malignancy, despite Post Transplant Lymphoproliferative disease. 11. Patients who are not eligible in the opinion of the physician. 12. Significant medical history and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality indicative of a significant underlying condition, that may interfere with patient’s safety, compliance, or study evaluations, according to the investigator’s opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Prolongation of kidney function and reduced viral infections after solid organ transplantation by monitoring of virus-specific T cells followed by therapeutic intervention.;Secondary Objective: 1) Reduction of viral infections after solid organ transplantation 2) Optimization of the individual timing of antiviral therapy 3) Optimization of the immunosuppressive therapy 4) Reduction of nephrotoxic effects of CsA and antiviral agents by optimized dosing 5) Premature study discontinuations due to AEs ;Primary end point(s): GFR (Cystatin C, Filler) 2 years after transplantation.;Timepoint(s) of evaluation of this end point: Week 2, Week 6, Week 8, Week 10, Week 12, monthly months 6-14, bimonthly months 15-20, month 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Reduction of viral infections after solid organ transplantation 2) Optimization of the individual timing of antiviral therapy 3) Optimization of the immunosuppressive therapy 4) Reduction of nephrotoxic effects of CsA and antiviral agents by optimized dosing 5) Premature study discontinuations due to AEs ;Timepoint(s) of evaluation of this end point: Week 2, Week 6, Week 8, Week 10, Week 12, monthly months 6-14, bimonthly months 15-20, month 24 | — |
Countries
Germany
Outcome results
None listed