Clinical Trials Logo
  1. Home
  2. Lung Diseases
  3. NCT02897895
  4. Details
NCT02897895 Clinical Trial

Study to Evaluate the Value of the Follow-up of CALCIneurin Activity to MOdulate Calcineurin Inhibitors-induced Immunosuppression in Lung Transplantation

Lung Diseases Clinical Trial

— CalciMo-TP  

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02897895
Other study ID # 2014-16
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 8, 2016
Last updated September 12, 2016
Start date December 2016
Est. completion date December 2022

Study information
Verified date September 2016
Source Assistance Publique Hopitaux De Marseille
Contact Martine Reynaud Gaubert, Professor
Email martine.reynaud@ap-hm.fr
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial Summary

The study is an interventional, multicentre, prospective, randomized, controlled, single-blind, comparative trial of two processes for adjusting the inhibitor of calcineurin (CNI) dosage in lung transplant recipients. Recipients will be stratified by transplant center and according to the underlying lung disease (affected with cystic fibrosis or not) and will be randomized to either evaluation of calcineurin activity (CN-a) in combination with CNI blood levels versus CNI blood levels alone in a 1:1 ratio. The objective is to compare the proportion of acute rejection that has required a specific curative treatment at 6 months after transplantation between patients in the two groups.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 134
Est. completion date December 2022
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient placed on the national waiting list for lung transplantation

- First de novo lung transplantation (single or double LTx)

- Prevention of allograft rejection by a usual immunosuppressive regimen including CNI (cyclosporine or tacrolimus)

Exclusion Criteria:

- Previous lung transplantation or other solid organ transplantation

- Combined lung transplantation with either liver or renal transplantation

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• levels of CNI in whole blood

• Calcineurin activity (CN-a) in peripheral blood mononuclear cells (PBMCs)

Locations
Country Name City State
France Assistance Publique Hopitaux de Marseille Marseille

Sponsors (1)
Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary number of episodes of acute rejection after LTx 6 months Yes
See also
  Status Clinical Trial Phase
Completed NCT05563701 - Evaluation of the LVivo Image Quality Scoring (IQS)
Completed NCT04908397 - Carnitine Consumption and Augmentation in Pulmonary Arterial Hypertension Phase 1
Terminated NCT03309358 - A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis Phase 1
Completed NCT03682354 - ESPB Versus INB With PCIA in Video-assisted Thoracic Surgery N/A
Enrolling by invitation NCT03683186 - A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension Phase 3
Completed NCT03626519 - Effects of Menthol on Dyspnoea in COPD Patients N/A
Recruiting NCT06004440 - Real World Registry for Use of the Ion Endoluminal System
Completed NCT04874948 - Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment Phase 1
Completed NCT02926768 - Phase I/II Study of CK-101 in NSCLC Patients and Other Advanced Solid Tumors Phase 1
Completed NCT01443845 - Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS) Phase 4
Completed NCT00281216 - Innate and Adaptive Immunity in Individuals Experiencing Chronic Obstructive Pulmonary Disease Exacerbations N/A
Completed NCT00269256 - Stress, Environment, and Genetics in Urban Children With Asthma N/A
Terminated NCT00233207 - IC14 Antibodies to Treat Individuals With Acute Lung Injury Phase 2
Recruiting NCT00129350 - Assessment of Heart and Heart-Lung Transplant Patient Outcomes Following Pulmonary Rehabilitation Phase 1
Active, not recruiting NCT00115297 - Montelukast for Early Life Wheezing Phase 2/Phase 3
Completed NCT00094276 - Intervention for Improving Asthma Care for Minority Children in Head Start N/A
Completed NCT00091767 - Genetic Studies in Difficult to Treat Asthma: TENOR N/A
Completed NCT00089752 - Continuous Positive Airway Pressure to Improve Milder Obstructive Sleep Apnea N/A
Completed NCT00233168 - Effectiveness of Public Health Model of Latent Tuberculosis Infection Control for High-Risk Adolescents N/A
Completed NCT00069823 - Study of Acid Reflux in Asthma Phase 3