Chronic Kidney Disease - Renal Epidemiology and Information Network

Renal Insufficiency, Chronic Clinical Trial

— CKD-REIN  

Official title:

Chronic Kidney Disease - Renal Epidemiology and Information Network: The CKD-REIN Cohort

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03381950
• Other study ID #: C12-30
• Status: Active, not recruiting
• Start date: July 2013
• Est. completion date: December 2026

Study information

• Verified date: October 2019
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3033
• Est. completion date: December 2026
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases
• Renal Insufficiency
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (14)

Lead Sponsor

Collaborator

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

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

References & Publications (12)

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 am — View Citation

Balkau B, Metzger M, Andreelli F, Frimat L, Speyer E, Combe C, Laville M, Jacquelinet C, Briançon 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 an — View 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 th — View 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. — View 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: Res — View 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 determinant — View Citation

Schweitzer ML, Stengel B, Legrand K, Briançon 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-R — View Citation

Stengel B, Combe C, Jacquelinet C, Briançon 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. — View Citation

Stengel B, Combe C, Jacquelinet C, Briançon S, Fouque D, Laville M, Frimat L, Pascal C, Herpe YÉ, 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. — View Citation

Stengel B, Metzger M, Combe C, Jacquelinet C, Briançon 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 — View 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 Ma — View Citation

Villain C, Metzger M, Combe C, Fouque D, Frimat L, Jacquelinet C, Laville M, Briançon S, Klein J, Schanstra JP, Robinson BM, Mansencal N, Stengel B, Massy ZA; Chronic Kidney Disease-Renal Epidemiology and Information Network (CKD-REIN) Study Investigators — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of end-stage renal disease (ESRD)	Dialysis, transplantation, conservative care management	up to 5 years
Secondary	Mortality	Specific and all-cause mortality	up to 5 years
Secondary	Incidence of major CKD events including acute kidney injury, cardiovascular and metabolic complications		up to 5 years
Secondary	Incidence of major adverse events including infections, cancer, mineral and bone disease, anemia, nutitional status, hospitalizations		up to 5 years
Secondary	Prescription drug use	For each drug prescription, the trade name, international non-proprietary name, ATC class, unit dose, defined daily dose, pharmaceutical formulation, and administration route are recorded. A linkage with the drug reimbursement files from the health insurance will be also performed.	up to 5 years
Secondary	Health-related Quality of life	Assessed by the Kidney Disease Quality of Life (KDQOL™) scale. It is a measure of kidney disease-related quality of life that comprises four subscales: Generic core [Physical Component Summary (PCS) and Mental Component Summary (MCS)]; Symptoms/Problems; Burden of Kidney Disease, and Effects of Kidney Disease. Scores of each subscale are calculated, ranged from 0 to 100, with higher scores reflecting better quality of life.	up to 5 years
Secondary	Depression	Assessed by the 10-item Center for Epidemiologic Studies Depression Scale (CESD). It is a screening test for depression and depressive disorder. A total score is reported.The possible range is 0 to 30, with the higher scores indicating more depression symptoms.	up to 5 years
Secondary	Cognitive function	The 30-item minimental status examination (MMSE) is a practical tool for evaluating cognitive status. A total score is reported, ranged from 0 to 30, with the higher scores indicating less cognitive impairment.	up to 5 years
Secondary	Physical Activity	The French translation of the Global Physical Activity Questionnaire (Version 2.0) is used to gather information on the time spent in moderate and vigorous physical activity and in sedentary behavior. The GPAQ contains 16 items designed to assess the frequency and duration of physical activity in 3 domains: during work, transportation, and leisure time as well as time spent sitting during a typical week. It distinguishes physical activity duration by min/day and min/week for each physical activity domain, which allows for calculating the energy expenditure scored in metabolic equivalent tasks (METs). According to duration and energy expenditure, physical activity level was classified as low, moderate, and high.	up to 5 years
Secondary	Family relationships	Assessed by the Family Relationships Index (FRI). the FRI provides a brief measure of family relations by assessing the way people currently perceive and describe their family. The scale consists of 12 items. Each item is coded from 1 to 4. A validation study of this questionnaire is planned.	up to 5 years
Secondary	Sleep disorders		up to 5 years
Secondary	Women's health	Set of questions regarding the menopause, menstrual cycle and contraception, and past/in progress pregnancies.	up to 5 years
Secondary	Cost effectiveness of different treatment practices and services	Several data sources will be used to estimate the cost of different treatment practices and services.; Patient-Level: key resource utilization indicators (e.g., hospitalization, clinic visits, prescription drug use), and procedures for costing these measures.; Clinic-level: The net costs of different treatment practices as well as structural characteristics (such as number of beds of the hospital, number of wards, number of hierarchical levels, for-profit or non for-profit status, teaching or not teaching hospital, spatial organization).	up to 5 years

External Links

•   The CKD-REIN Website