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Renal Insufficiency, ChronicCKD-REINNCT03381950

Chronic Kidney Disease - Renal Epidemiology and Information Network

An observational study of Renal Insufficiency, Chronic, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Insufficiency, Chronic
How many people
3,033 participants
Where
1 siteFrance
Study dates
1 Jul 2013to 18 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with CKD Stage 3-5 (eGFR <60 ml/min/1.73m2, not on dialysis or with kidney transplant) receiving nephrology care

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Inserm U1018, UPS-UVSQ, CESP, Renal and Cardiovascular Epidemiology team. 16 avenue Paul Vaillant Couturier

    Villejuif, 94807

Other trials in France

About this study

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

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.
Read the 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.

Keywords
chronic kidney disease, prospective cohort study, risk profile, patient-reported-outcomes
Medical subject headings
Renal Insufficiency, Chronic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of end-stage renal disease (ESRD)

    Dialysis, transplantation, conservative care management

    Measured: up to 5 years

Secondary outcomes (12)

  1. Mortality

    Specific and all-cause mortality

    Measured: up to 5 years

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

    Measured: up to 5 years

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

    Measured: up to 5 years

  4. 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.

    Measured: up to 5 years

  5. 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.

    Measured: up to 5 years

  6. 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.

    Measured: up to 5 years

  7. 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.

    Measured: up to 5 years

  8. 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.

    Measured: up to 5 years

  9. 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.

    Measured: up to 5 years

  10. Sleep disorders

    Measured: up to 5 years

  11. Women's health

    Set of questions regarding the menopause, menstrual cycle and contraception, and past/in progress pregnancies.

    Measured: up to 5 years

  12. 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).

    Measured: up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2017
  2. Study start1 Jul 2013
  3. Primary completion3 May 2016
  4. Study completion18 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,033 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03381950
Sponsor's protocol ID
C12-30
Acronym
CKD-REIN
Status last verified
Jun 2026
First submitted
11 Dec 2017
Last updated
5 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 24064325

  • 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.

    PubMed 26976057

  • 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.

    PubMed 30980562

  • 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.

    PubMed 28915857

  • 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.

    PubMed 30169874

  • 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.

    PubMed 30110711

  • 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.

    PubMed 29706470

  • 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.

    PubMed 29635335

  • 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.

    PubMed 30659448

  • 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.

    PubMed 30975656

  • 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.

    PubMed 31493530

  • 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.

    PubMed 31169352

  • Hamroun A, Frimat L, Laville M, Metzger M, Combe C, Fouque D, Jacquelinet C, Ayav C, Liabeuf S, Lange C, Herpe YE, Zee J, Glowacki F, Massy ZA, Robinson B, Stengel B; Chronic Kidney Disease-Renal Epidemiology and Information Network (CKD-REIN) study group. New insights into acute-on-chronic kidney disease in nephrology patients: the CKD-REIN study. Nephrol Dial Transplant. 2022 Aug 22;37(9):1700-1709. doi: 10.1093/ndt/gfab249.

    PubMed 34473306

  • Alencar de Pinho N, Capgras JB, Speyer E, Combe C, Fouque D, Frimat L, Massy Z, Ayav C, Liabeuf S, Lange C, Jacquelinet C, Stengel B, Pascal C, Laville M; au nom du groupe d'etude de la cohorte Chronic Kidney Disease-Renal Epidemiology Information Network (CKD-REIN). [CKD care in French nephrology practices]. Nephrol Ther. 2021 Dec;17(7):496-506. doi: 10.1016/j.nephro.2021.06.008. Epub 2021 Aug 10. French.

    PubMed 34384728

  • Massy ZA, Kolla E, Ferrieres J, Bruckert E, Lambert O, Mansencal N, Laville M, Frimat L, Fouque D, Combe C, Pecoits-Filho R, Stengel B, Liabeuf S; CKD-REIN Collaborators. Is a treat-to-target approach to lipid-lowering therapy appropriate in patients with chronic kidney disease? A prospective French cohort study. J Nephrol. 2021 Oct;34(5):1467-1477. doi: 10.1007/s40620-021-01086-y. Epub 2021 Jun 11.

    PubMed 34117621

Questions about this trial

What is this clinical trial studying?

An observational study of Renal Insufficiency, Chronic, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of end-stage renal disease (ESRD) (time frame: up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03381950, which also lists 37 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.

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