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

NCT03305211 | Unknown

• 1 other identifier: 2017-49
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Blood and urinary biomarkers in renal disease

  biological assay

  one day

Study Arms (1)

Biological sample

OTHER

biological sampling will be performed on patients requiring renal biopsy and well-phenotyped patients (diagnosis of renal disease)

Other: sample

Interventions

sample OTHER

Participation in NephroMIC involves additional blood samples of 5 tubes (35 mL) and an additional sample of fresh urine.

Biological sample

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique des Hôpitaux de Marseille Hôpital de la Conception

Marseille, 13354, France

Location

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Urielle DESALBRES

  Assistance Publique Hôpitaux de Marseille

  STUDY DIRECTOR

Central Study Contacts

Noémie JOURDE-CHICHE

CONTACT

04 91 38 30 42; noemie.jourde@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: patients requiring renal biopsy for medical reasons

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: October 9, 2017
• Study Start: December 15, 2017
• Primary Completion: December 15, 2022
• Study Completion: April 20, 2023
• Last Updated: October 9, 2017

Record last verified: 2017-10

Locations

FR (1)