Chronic Kidney Disease - Renal Epidemiology and Information Network

NCT ID: NCT03381950

Last Updated: 2019-10-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 3033 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2026-12-31

Brief Summary

Preserving kidney function and improving the transition from CKD to End stage renal disease (ESRD) is a research and healthcare challenge. The Chronic Kidney Disease-Renal Epidemiology and Information Network (CKD-REIN) cohort was established to identify the determinants, biomarkers and practice patterns associated with chronic kidney disease outcomes. The study includes 3,033 adult patients with moderate to advanced CKD from a representative sample of 40 nephrology clinics in France with respect to regions and legal status. Patients are recruited during a routine visit and followed up for 5 years, before and after starting renal replacement therapy. Patient-level clinical, biological, and lifestyle data are collected annually, as well as provider-level data on clinical practices, coordinated with the International Chronic Kidney Disease Outcomes and Practice Pattern Study (CKDopps). Blood and urine samples are stored in a biobank. The overall objective is to develop a research platform to address key questions regarding the determinants and biomarkers associated with adverse outcomes in CKD and to assess its effective management. It has the following hypotheses and specific aims:

1. to evaluate a large set of social, environmental, bioclinical, and genetic factors, and their interactions in relation with CKD outcomes including progression to ESRD, mortality, metabolic and vascular complications, and the onset of a number of chronic and acute events;

2. to assess several new biomarkers to predict adverse outcomes of CKD and its complications;

3. to evaluate the associations of provider practices (management of hypertension, anemia, nutritional abnormalities, mineral and bone disorder, nutritional status, timing of dialysis initiation and transplant wait-listing) with achievement of clinical practice guidelines, clinical and patient-reported outcomes (PRO).

4. to evaluate the associations of health care organization and clinic services (e.g., for nutrition, educational programs) with clinical and patient-reported outcomes, and achievement of clinical practice guidelines;

5. to estimate the relative cost-effectiveness of different provider practices and clinic services.

Detailed Description

All cohort participants are assessed annually for at least 5 years, until 6 months after the start of renal replacement therapy.

Each year, data are collected from both medical records and patients interview and self-administrated questionnaires are asked to report clinical events.

Interviews and routine biological measurements are repeated annually.

CKD-REIN is funded by the Agence Nationale de la Recherche through the 2010 'Cohortes-Investissements d'Avenir' programme and by the 2010 national Programme Hospitalier de Recherche Clinique.

CKD-REIN is also supported through a public-private partnership with Amgen, Fresenius Medical Care, and GlaxoSmithKline since 2012; Baxter and MerckSharp&Dohme-Chibret (France) from 2012 to 2017; LillyFrance since 2013; Otsuka Pharmaceutical since 2015; Vifor Fresenius since 2017; AstraZeneca since 2018; and Sanofi-Genzyme from 2012 to 2015.

Conditions

Renal Insufficiency, Chronic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• eGFR < 60 ml/min/1.73m2 for at least 1 month
• no prior chronic dialysis or transplantation
• Written Signed consent form

Exclusion Criteria

• Age <18 yrs old,
• Pregnant female,
• patients who plan to move
• Unable to give inform consent,
• Decline to participate

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Université Paris-Sud

OTHER

Sponsor Role: collaborator

Agence de La Biomédecine

OTHER_GOV

Sponsor Role: collaborator

Arbor Research Collaborative for Health

OTHER

Sponsor Role: collaborator

Hospital Ambroise Paré Paris

OTHER

Sponsor Role: collaborator

Centre Hospitalier Lyon Sud

OTHER

Sponsor Role: collaborator

Central Hospital, Nancy, France

OTHER

Sponsor Role: collaborator

Institut de Formation et de Recherche sur les Organisations Sanitaires et Sociales

UNKNOWN

Sponsor Role: collaborator

Biobanque de Picardie

UNKNOWN

Sponsor Role: collaborator

Centre National de Génotypage

OTHER

Sponsor Role: collaborator

Institut des Maladies Métaboliques et Cardiovasculaires

UNKNOWN

Sponsor Role: collaborator

Etablissement Français du Sang

OTHER

Sponsor Role: collaborator

Amiens University Hospital

OTHER

Sponsor Role: collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role: collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bénédicte Stengel, MD

Role: PRINCIPAL_INVESTIGATOR

Inserm U1018, UPS-UVSQ, CESP, Renal and Cardiovascular Epidemiology team, Paris, France

References

Stengel B, Combe C, Jacquelinet C, Briancon S, Fouque D, Laville M, Frimat L, Pascal C, Herpe YE, Deleuze JF, Schanstra J, Pisoni RL, Robinson BM, Massy ZA. The French Chronic Kidney Disease-Renal Epidemiology and Information Network (CKD-REIN) cohort study. Nephrol Dial Transplant. 2014 Aug;29(8):1500-7. doi: 10.1093/ndt/gft388. Epub 2013 Sep 24.

Reference Type: BACKGROUND

PMID: 24064325 (View on PubMed)

Stengel B, Combe C, Jacquelinet C, Briancon S, Fouque D, Laville M, Frimat L, Pascal C, Herpe YE, Morel P, Deleuze JF, Schanstra JP, Pisoni RL, Robinson BM, Massy ZA. [The French Chronic Kidney Disease-Renal Epidemiology and Information Network (CKD-REIN) cohort study: To better understand chronic kidney disease]. Nephrol Ther. 2016 Apr;12 Suppl 1:S49-56. doi: 10.1016/j.nephro.2016.01.005. Epub 2016 Mar 11. French.

Reference Type: BACKGROUND

PMID: 26976057 (View on PubMed)

Laville SM, Stengel B, Massy ZA, Liabeuf S. Reply to "Restricting maintenance allopurinol dose according to kidney function in patients with gout is inappropriate!" by Stamp et al. Br J Clin Pharmacol. 2019 Jun;85(6):1380-1381. doi: 10.1111/bcp.13924. Epub 2019 Apr 13. No abstract available.

Reference Type: BACKGROUND

PMID: 30980562 (View on PubMed)

Affret A, Wagner S, El Fatouhi D, Dow C, Correia E, Niravong M, Clavel-Chapelon F, De Chefdebien J, Fouque D, Stengel B; CKD-REIN study investigators; Boutron-Ruault MC, Fagherazzi G. Validity and reproducibility of a short food frequency questionnaire among patients with chronic kidney disease. BMC Nephrol. 2017 Sep 15;18(1):297. doi: 10.1186/s12882-017-0695-2.

Reference Type: RESULT

PMID: 28915857 (View on PubMed)

Villain C, Metzger M, Combe C, Fouque D, Frimat L, Jacquelinet C, Laville M, Briancon S, Klein J, Schanstra JP, Robinson BM, Mansencal N, Stengel B, Massy ZA. Prevalence of atheromatous and non-atheromatous cardiovascular disease by age in chronic kidney disease. Nephrol Dial Transplant. 2020 May 1;35(5):827-836. doi: 10.1093/ndt/gfy277.

Reference Type: RESULT

PMID: 30169874 (View on PubMed)

Laville SM, Metzger M, Stengel B, Jacquelinet C, Combe C, Fouque D, Laville M, Frimat L, Ayav C, Speyer E, Robinson BM, Massy ZA, Liabeuf S; Chronic Kidney Disease-Renal Epidemiology and Information Network (CKD-REIN) Study Collaborators. Evaluation of the adequacy of drug prescriptions in patients with chronic kidney disease: results from the CKD-REIN cohort. Br J Clin Pharmacol. 2018 Dec;84(12):2811-2823. doi: 10.1111/bcp.13738. Epub 2018 Sep 24.

Reference Type: RESULT

PMID: 30110711 (View on PubMed)

Balkau B, Metzger M, Andreelli F, Frimat L, Speyer E, Combe C, Laville M, Jacquelinet C, Briancon S, Ayav C, Massy Z, Pisoni RL, Stengel B, Fouque D. Impact of sex and glucose-lowering treatments on hypoglycaemic symptoms in people with type 2 diabetes and chronic kidney disease. The French Chronic Kidney Disease - Renal Epidemiology and Information Network (CKD-REIN) Study. Diabetes Metab. 2019 Apr;45(2):175-183. doi: 10.1016/j.diabet.2018.03.007. Epub 2018 Apr 6.

Reference Type: RESULT

PMID: 29706470 (View on PubMed)

Stengel B, Metzger M, Combe C, Jacquelinet C, Briancon S, Ayav C, Fouque D, Laville M, Frimat L, Pascal C, Herpe YE, Morel P, Deleuze JF, Schanstra JP, Lange C, Legrand K, Speyer E, Liabeuf S, Robinson BM, Massy ZA. Risk profile, quality of life and care of patients with moderate and advanced CKD: The French CKD-REIN Cohort Study. Nephrol Dial Transplant. 2019 Feb 1;34(2):277-286. doi: 10.1093/ndt/gfy058.

Reference Type: RESULT

PMID: 29635335 (View on PubMed)

Schweitzer ML, Stengel B, Legrand K, Briancon S, Jacquelinet C, Combe C, Fouque D, Massy ZA, Laville M, Frimat L, Ayav C. Obesity phenotype and patient-reported outcomes in moderate and severe chronic kidney disease: a cross-sectional study from the CKD-REIN cohort study. Qual Life Res. 2019 Jul;28(7):1873-1883. doi: 10.1007/s11136-019-02110-2. Epub 2019 Jan 18.

Reference Type: RESULT

PMID: 30659448 (View on PubMed)

Sukul N, Speyer E, Tu C, Bieber BA, Li Y, Lopes AA, Asahi K, Mariani L, Laville M, Rayner HC, Stengel B, Robinson BM, Pisoni RL; CKDopps and CKD-REIN investigators. Pruritus and Patient Reported Outcomes in Non-Dialysis CKD. Clin J Am Soc Nephrol. 2019 May 7;14(5):673-681. doi: 10.2215/CJN.09600818. Epub 2019 Apr 11.

Reference Type: RESULT

PMID: 30975656 (View on PubMed)

Liabeuf S, McCullough K, Young EW, Pisoni R, Zee J, Reichel H, Pecoits-Filho R, Port FK, Stengel B, Csomor PA, Metzger M, Robinson B, Massy ZA. International variation in the management of mineral bone disorder in patients with chronic kidney disease: Results from CKDopps. Bone. 2019 Dec;129:115058. doi: 10.1016/j.bone.2019.115058. Epub 2019 Sep 4.

Reference Type: RESULT

PMID: 31493530 (View on PubMed)

Pecoits-Filho R, Fliser D, Tu C, Zee J, Bieber B, Wong MMY, Port F, Combe C, Lopes AA, Reichel H, Narita I, Stengel B, Robinson BM, Massy Z; CKDopps Investigators. Prescription of renin-angiotensin-aldosterone system inhibitors (RAASi) and its determinants in patients with advanced CKD under nephrologist care. J Clin Hypertens (Greenwich). 2019 Jul;21(7):991-1001. doi: 10.1111/jch.13563. Epub 2019 Jun 6.

Reference Type: RESULT

PMID: 31169352 (View on PubMed)

Laville SM, Jaisson S, Gillery P, Okwieka A, Alencar de Pinho N, Combe C, Mansencal N, Massy ZA, Liabeuf S; CKD-REIN study collaborators. Homocitrulline Is Associated with Cardiovascular Outcomes in Nondialysis Patients with CKD. Kidney360. 2025 Apr 1;6(8):1328-1337. doi: 10.34067/KID.0000000797.

Reference Type: DERIVED

PMID: 40168087 (View on PubMed)

El Chamieh C, Larabi IA, Laville SM, Jacquelinet C, Combe C, Fouque D, Laville M, Frimat L, Pecoits-Filho R, Lange C, Stengel B, Alencar De Pinho N, Alvarez JC, Massy ZA, Liabeuf S; Chronic Kidney Disease-Renal Epidemiology and Information Network (CKD-REIN) Study Group. Proton-Pump Inhibitors and Serum Concentrations of Uremic Toxins in Patients with Chronic Kidney Disease. Toxins (Basel). 2023 Apr 7;15(4):276. doi: 10.3390/toxins15040276.

Reference Type: DERIVED

PMID: 37104214 (View on PubMed)

Montalescot L, Dorard G, Speyer E, Legrand K, Ayav C, Combe C, Stengel B, Untas A. The experience of relatives and friends of patients with moderate to advanced chronic kidney disease: Insights from the CKD-REIN cohort study. Br J Health Psychol. 2023 Nov;28(4):930-951. doi: 10.1111/bjhp.12662. Epub 2023 Apr 20.

Reference Type: DERIVED

PMID: 37080946 (View on PubMed)

Pepin M, Levassort H, Boucquemont J, Lambert O, Alencar de Pinho N, Turinici M, Helmer C, Metzger M, Cheddani L, Frimat L, Combe C, Fouque D, Laville M, Ayav C, Liabeuf S, Jacquelinet C, Teillet L, Stengel B, Massy ZA; CKD-REIN Study Collaborators. Cognitive performance is associated with glomerular filtration rate in patients with chronic kidney disease: results from the CKD-REIN cohort. J Neurol Neurosurg Psychiatry. 2023 Jun;94(6):457-466. doi: 10.1136/jnnp-2022-330347. Epub 2023 Jan 24.

Reference Type: DERIVED

PMID: 36693722 (View on PubMed)

Wagner S, Merkling T, Metzger M, Koppe L, Laville M, Boutron-Ruault MC, Frimat L, Combe C, Massy ZA, Stengel B, Fouque D. Probiotic Intake and Inflammation in Patients With Chronic Kidney Disease: An Analysis of the CKD-REIN Cohort. Front Nutr. 2022 Mar 30;9:772596. doi: 10.3389/fnut.2022.772596. eCollection 2022.

Reference Type: DERIVED

PMID: 35433774 (View on PubMed)

Montalescot L, Speyer E, Legrand K, Ayav C, Combe C, Stengel B, Untas A. Reliability and validity of the French adaptation of the Family Relationship Index-short form in patients' with chronic kidney disease. J Health Psychol. 2022 Jan;27(1):166-175. doi: 10.1177/1359105320949921. Epub 2020 Aug 10.

Reference Type: DERIVED

PMID: 32772863 (View on PubMed)

Laville SM, Gras-Champel V, Moragny J, Metzger M, Jacquelinet C, Combe C, Fouque D, Laville M, Frimat L, Robinson BM, Stengel B, Massy ZA, Liabeuf S; Chronic Kidney Disease-Renal Epidemiology and Information Network (CKD-REIN) Study Group. Adverse Drug Reactions in Patients with CKD. Clin J Am Soc Nephrol. 2020 Aug 7;15(8):1090-1102. doi: 10.2215/CJN.01030120. Epub 2020 Jul 1.

Reference Type: DERIVED

PMID: 32611662 (View on PubMed)

Related Links

https://ckdrein.inserm.fr

The CKD-REIN Website

Other Identifiers

C12-30

Identifier Type: -

Identifier Source: org_study_id