Chronic Kidney Disease - Renal Epidemiology and Information Network

NCT03381950 | Active Not Recruiting

• 1 other identifier: C12-30
• Study Type: observational
• Target: 3,033
• Locations: 0 countries
• Sites: N/A

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. 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. 2.to assess several new biomarkers to predict adverse outcomes of CKD and its complications;
3. 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. 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. 5.to estimate the relative cost-effectiveness of different provider practices and clinic services.

Conditions

Renal Insufficiency, Chronic

Keywords

chronic kidney disease; prospective cohort study; risk profile; patient-reported-outcomes

Outcome Measures

Primary Outcomes (1)

• Incidence of end-stage renal disease (ESRD)

  Dialysis, transplantation, conservative care management

  up to 5 years

Secondary Outcomes (12)

• Mortality

  up to 5 years

• Incidence of major CKD events including acute kidney injury, cardiovascular and metabolic complications

  up to 5 years

• Incidence of major adverse events including infections, cancer, mineral and bone disease, anemia, nutitional status, hospitalizations

  up to 5 years

• Prescription drug use

  up to 5 years

• Health-related Quality of life

  up to 5 years

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead
• Université Paris-Sud: collaborator
• Agence de La Biomédecine: collaborator
• Arbor Research Collaborative for Health: collaborator
• Hospital Ambroise Paré Paris: collaborator
• Centre Hospitalier Lyon Sud: collaborator
• Central Hospital, Nancy, France: collaborator
• Institut de Formation et de Recherche sur les Organisations Sanitaires et Sociales: collaborator
• Biobanque de Picardie: collaborator
• Centre National de Génotypage: collaborator
• Institut des Maladies Métaboliques et Cardiovasculaires: collaborator
• Etablissement Français du Sang: collaborator
• Amiens University Hospital: collaborator
• University Hospital, Bordeaux: collaborator

Related Publications (19)

• 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.

  PMID: 24064325 BACKGROUND

• 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.

  PMID: 26976057 BACKGROUND

• 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.

  PMID: 30980562 BACKGROUND

• 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.

  PMID: 28915857 RESULT

• 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.

  PMID: 30169874 RESULT

• 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.

  PMID: 30110711 RESULT

• 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.

  PMID: 29706470 RESULT

• 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.

  PMID: 29635335 RESULT

• 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.

  PMID: 30659448 RESULT

• 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.

  PMID: 30975656 RESULT

• 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.

  PMID: 31493530 RESULT

• 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.

  PMID: 31169352 RESULT

• 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.

  PMID: 40168087 DERIVED

• 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.

  PMID: 37104214 DERIVED

• 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.

  PMID: 37080946 DERIVED

• 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.

  PMID: 36693722 DERIVED

• 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.

  PMID: 35433774 DERIVED

• 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.

  PMID: 32772863 DERIVED

• 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.

  PMID: 32611662 DERIVED

Related Links

• The CKD-REIN Website

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma and urine samples are collected and stored on all patients at enrollment and study end, and in a subsample of 1,200 at 2-year follow-up.

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bénédicte Stengel, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: December 22, 2017
• Study Start: July 1, 2013
• Primary Completion: July 1, 2021
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 11, 2019

Record last verified: 2019-10