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Biological Collection in Nephrology for the Study of the Links Between Kidney Disease, Immunity System and Cardiovascular Complications (NéphroMIC²)

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ClinicalTrials.gov Identifier: NCT03305211
Recruitment Status : Not yet recruiting
First Posted : October 9, 2017
Last Update Posted : October 9, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:

The NephoMIC project is a biological collection in patients of Nephrology, allowing the study of the links between kidney diseases, Immunity system and Cardiovascular complications.

Its aim is to allow the development of a translational research on the theme of "Systemic Nephrology", which concerns both renal complications of autoimmune and inflammatory diseases, and systemic complications of patients with kidney disease, linked to both a state of immunosuppression and an increased risk of cardiovascular complications.

It is based on the proximity between the Clinical investigation Center (CIC) of the hospital, where the samples are received, techniqued and preserved, and the Center of Nephrology and Renal Transplantation of the hospital.

The collection includes blood samples (whole blood, serum, plasma, total blood RNA, PBMC cells), and urine samples (fresh urine).

Participation in the collection is particularly recommended for patients who require a medical renal biopsy in the Nephrology Department. Other well-phenotyped patients (well-defined renal disease diagnosis) may also participate in NephroMIC.


Condition or disease Intervention/treatment Phase
Kidney Disease Other: sample Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Intervention Model: Single Group Assignment
Intervention Model Description: patients requiring renal biopsy for medical reasons
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Biological Collection in Nephrology for the Study of the Links Between Kidney Disease, Immunity System and Cardiovascular Complications
Estimated Study Start Date : December 15, 2017
Estimated Primary Completion Date : December 15, 2022
Estimated Study Completion Date : April 20, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Biological sample
biological sampling will be performed on patients requiring renal biopsy and well-phenotyped patients (diagnosis of renal disease)
Other: sample
Participation in NephroMIC involves additional blood samples of 5 tubes (35 mL) and an additional sample of fresh urine.




Primary Outcome Measures :
  1. Blood and urinary biomarkers in renal disease [ Time Frame: one day ]
    biological assay



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult Patient (> 18 years)
  • Patient with renal disease
  • Patient who signed consent to participate in the study

Exclusion Criteria:

  • Pregnant woman
  • Severe anemia (Hb <7 g / dL)
  • Patient deprived of liberty
  • Patient not affiliated to a Social Security scheme

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03305211


Contacts
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Contact: Noémie JOURDE-CHICHE 04 91 38 30 42 noemie.jourde@ap-hm.fr

Locations
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France
Assistance Publique des Hôpitaux de Marseille Hôpital de la Conception Not yet recruiting
Marseille, France, 13354
Contact: Noémie JOURDE-CHICHE    04 91 38 30 42    noemie.jourde@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Urielle DESALBRES Assistance Publique Hôpitaux de Marseille

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03305211     History of Changes
Other Study ID Numbers: 2017-49
First Posted: October 9, 2017    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases