Clinical trial NCT03381950: Chronic Kidney Disease - Renal Epidemiology and Information Network
Official title: Chronic Kidney Disease - Renal Epidemiology and Information Network: The CKD-REIN Cohort
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Renal Insufficiency, Chronic
Keywords: chronic kidney disease
prospective cohort study
risk profile
patient-reported-outcomes
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
Collaborators: name: Université Paris-Sud
name: Agence de La Biomédecine
name: Arbor Research Collaborative for Health
name: Hospital Ambroise Paré Paris
name: Centre Hospitalier Lyon Sud
name: Central Hospital, Nancy, France
name: Institut de Formation et de Recherche sur les Organisations Sanitaires et Sociales
name: Biobanque de Picardie
name: Centre National de Génotypage
name: Institut des Maladies Métaboliques et Cardiovasculaires
name: Etablissement Français du Sang
name: Amiens University Hospital
name: University Hospital, Bordeaux
First posted: 2017-12-22
Enrollment: 3033
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with CKD Stage 3-5 (eGFR \<60 ml/min/1.73m2, not on dialysis or with kidney transplant) receiving nephrology care

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.

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

Primary outcomes:
measure: Incidence of end-stage renal disease (ESRD)
timeFrame: up to 5 years
Secondary outcomes:
measure: Mortality
timeFrame: up to 5 years
measure: Incidence of major CKD events including acute kidney injury, cardiovascular and metabolic complications
timeFrame: up to 5 years
measure: Incidence of major adverse events including infections, cancer, mineral and bone disease, anemia, nutitional status, hospitalizations
timeFrame: up to 5 years
measure: Prescription drug use
timeFrame: up to 5 years
measure: Health-related Quality of life
timeFrame: up to 5 years
measure: Depression
timeFrame: up to 5 years
measure: Cognitive function
timeFrame: up to 5 years
measure: Physical Activity
timeFrame: up to 5 years
measure: Family relationships
timeFrame: up to 5 years
measure: Sleep disorders
timeFrame: up to 5 years
measure: Women's health
timeFrame: up to 5 years
measure: Cost effectiveness of different treatment practices and services
timeFrame: up to 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Inserm U1018, UPS-UVSQ, CESP, Renal and Cardiovascular Epidemiology team, Paris, France
name: Bénédicte Stengel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.