Efficacy of everolimus on top to centre specific standard immunosuppressive regimen in lung transplant recipients

Phase 1

• Conditions: lung transplantation; MedDRA version: 14.0Level: LLTClassification code 10050433Term: Prophylaxis against lung transplant rejectionSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2011-001539-21-DE
• Lead Sponsor: ovartis Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-10
• Last Update Posted: 10 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Adult recipients of de novo cadaveric lung transplants older than 18 years, 3-18 months prior to enrolment
2.Patients with impaired (mild/moderate) renal function, i.e. GFR >50 and <90mL/min measured by CKD EPI prior inclusion, confirmed by two independent measurements
3.Patients able to take oral medication at time of randomization
4.Patients on a CNI-containing triple immunosuppressive regimen at time of randomization
5.Patients who are willing and able to participate in the study and from whom written informed consent has been obtained

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 172
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1.Patients who are recipients of multiple solid organ or islet cell tissue transplants, or have previously received an organ or tissue transplant
2.Patients with pre-transplant immunosuppressive CNI- or everolimus containing treatment
3.Patients with renal failure or CKD/ESRD who require renal replacement therapy within 7 days prior to randomization or who required renal replacement therapy for clearance for more than 2 weeks prior to transplantation
4.Patients who are recipients of A-B-O incompatible transplant grafts
5.Patients with any known hypersensitivity to everolimus, mycophenolic acid, tacrolimus, cyclosporine A, steroids, other drugs similar to everolimus (e.g., macrolides), or other components of the formulations (e.g. lactose, see also SmPCs)
6.Patients who have received an investigational drug within 30 days prior to randomization
7.Two episodes of acute rejection that required antibody therapy or more than one steroid sensitive episode of acute rejection in the last 3 months prior to randomization. This includes patients who have not completed steroid treatment for acute rejection within 7 days prior to randomization
8.Patients receiving plasmaphoresis or immunomodulatory antibody treatment within 6 months prior to randomization
9.Patients with thrombocytopenia (platelets <100,000/mm³), with an absolute neutrophil count of <1,500/mm³ or leucopenia (leucocytes <3000/mm³), with anemia with Hb < 8g/dl at time of screening
10.Patients with uncontrolled hypercholesterolemia (>330mg/dL; >9mmol/L) or hypertriglyceridemia (>300 mg/dL; >8.5 mmol/L) at time of screening
11.Patients with a creatinine/protein ratio indicating daily urinary protein excretion >1g/24h at time of randomization
12.Patients with history of thrombotic microangiopathies
13.Patients with history of Burkholderia cepacia complex colonisation
14.Patients with BOS ( > grade 1) at time of randomization
15.Patients with history of inability to maintain to CNI target levels in more than 6 of the last 10 measurements according to investigator’s discretion.
16.Patients with symptoms of significant mental illness and with inability to cooperate or communicate with the investigator. Patients who are unlikely to comply with the study requirements, or who are unable to give informed consent
17.Patients with a history of malignancy of any organ system, treated or untreated, during the last five years, whether or not there is evidence of local recurrence or metastases, except squamous or basal cell carcinoma of the skin
18.Patients who are in a intensive care setting in the last 30 days before randomization
19. Patients who are HIV positive or Hepatitis B surface antigen positive or Hepatitis C (PCR+ only) virus positive
20.Patients with clinically significant systemic infection at time of randomization
21.Females who are pregnant or breast feeding (pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml))
22.The reproductive-developmental toxicity profile of the study drug, the study design, and the study’s target population will guide the schedule for pregnancy tests to be performed throughout the study.
23.Women who are pregnant or breast feeding
24.Patients, who have already been randomized into this study earlier must not be included a second time
25.Evidence of unsolved drug or alcohol addiction
26.Study personne

Study & Design

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