Viral load guided Immunosuppression after Lung Transplantatio

Phase 1

• Conditions: Prophylaxis against lung transplant rejectionClinical experience suggests that individual tailoring of immunosuppression for patients after lung transplantation could potentially optimize patient outcome.

• Registration Number: EUCTR2019-001770-29-AT
• Lead Sponsor: Philipps-Universität Marburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-04
• Last Update Posted: 21 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

1.patients 21 to 42 days after de novo lung transplantation (bilateral or combined)
2.age = 18 years
3.tacrolimus based immunosuppression
4.written informed consent
5.detectable TTV load at randomization (>2,7 log 10)
6.negative serum pregnancy test in women of childbearing potential.
7.Women of childbearing capacity are required to have a negative serum pregnancy test before treatment and must agree to maintain highly effective methods of contraception by practicing abstinence or by using at least two methods of birth control from the date of consent through the end of the study. If abstinence is not practiced, a combination of hormonal contraceptive (oral, injectable or implants) and a barrier method (condom, diaphragm with a vaginal spermicidal agent) has to be used.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 144
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. history or high-risk of obstructive airway complications after lung transplantation
2.respiratory failure (need for oxygen therapy or ventilation at screening after lung transplantation)
3.inability to undergo transbronchial biopsy
4.advanced kidney failure (GFR CKD-EPI <30 ml/min/1.73m2 at inclusion and/or current renal replacement therapy at inclusion or randomization
5.advanced liver cirrhosis (CHILD-Pugh Score C) after lung transplantation
6.fluctuating tacrolimus drug levels (less than 20% in target range after transplantation)
7.patients with symptoms of significant mental illness and with inability to cooperate or communicate with the investigator.
8.unlikeliness to comply with the study requirements
9.HIV positivity
10.evidence of unsolved drug or alcohol addiction
11.breastfeeding women
12.simultaneous participation in other clinical trials if not permitted by the steering committee

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified