Characteristics,Treatment Course and Prognosis of Patients Older Than 75 Yrs Old Reaching End Stage Renal Disease (PSPA)

NCT02910908 | Completed

• 1 other identifier: 30RC15_0144-PSPA
• Study Type: observational
• Target: 581
• Locations: 0 countries
• Sites: N/A

Brief Summary

Elderly (i.e.\>75 yrs) represent about 40% of incident dialysis patients in the French REIN Registry and are growing population in high income countries. Those elderly patients with CKD have a high risk of dying within the first months of dialysis start or could have a good long-term prognosis suggesting kidney transplantation access. Elderly patients with CKD also have a higher risk of dying than reaching ESRD. Therefore, outcomes of elderly patients with advanced CKD need to be better described and understood to be able to give accurate information to the patients and their relatives and help decision making concerning the treatment strategy including several options (i.e preemptive kidney transplantation, in center or home dialysis and conservative care). In France we have information about patients who started dialysis with French dialysis registry (REIN) but not about elderly patient treated with conservative care. Then we don't have information about description of the therapeutic project in this population and their evolution in a prospective cohort design. Finally we need to identify patients with high risk of early mortality to help shared decision making for better care organisation. The project of the study is the development of a French multicenter prospective cohort including elderly patients more than 75 years old reaching ESRD. Objectives are as follow: Description of the characteristics of the population such as, clinical and social conditions, medicine treatment, therapeutic project declared by nephrologist and laboratory value at inclusion. Description of the evolution of therapeuic project, kidney function and the outcomes defined as death or dialysis or kidney transplantation. Development of a mortality prognosis tools to help decision making in this population.

Conditions

Kidney Failure, Chronic

Keywords

Elderly; ESRD prognosis; help decision making dialysis therapeutic project

Outcome Measures

Primary Outcomes (2)

• Mortality

  Five years

• Has dialysis started? yes/no

  Five years

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Elderly patients follow by nephrologist with CKD and eGFR less than 20 mL/min/1.73 m2 (estimated by sMDRD formula)

You may qualify if:

• Patients were age older than 75 \> years,
• Chronic Kidney Disease with eGFR less than 20 mL/min/1.73 m2 (estimated by sMDRD formula)

You may not qualify if:

• Acute renal failure and late referral defined by dialysis starting without previous nephrologist follow-up

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Related Publications (5)

• Couchoud C, Labeeuw M, Moranne O, Allot V, Esnault V, Frimat L, Stengel B; French Renal Epidemiology and Information Network (REIN) registry. A clinical score to predict 6-month prognosis in elderly patients starting dialysis for end-stage renal disease. Nephrol Dial Transplant. 2009 May;24(5):1553-61. doi: 10.1093/ndt/gfn698. Epub 2008 Dec 18.

  PMID: 19096087 BACKGROUND

• Joly D, Anglicheau D, Alberti C, Nguyen AT, Touam M, Grunfeld JP, Jungers P. Octogenarians reaching end-stage renal disease: cohort study of decision-making and clinical outcomes. J Am Soc Nephrol. 2003 Apr;14(4):1012-21. doi: 10.1097/01.asn.0000054493.04151.80.

  PMID: 12660336 BACKGROUND

• Hemmelgarn BR, James MT, Manns BJ, O'Hare AM, Muntner P, Ravani P, Quinn RR, Turin TC, Tan Z, Tonelli M; Alberta Kidney Disease Network. Rates of treated and untreated kidney failure in older vs younger adults. JAMA. 2012 Jun 20;307(23):2507-15. doi: 10.1001/jama.2012.6455.

  PMID: 22797451 BACKGROUND

• Moranne O, Couchoud C, Kolko-Labadens A, Allot V, Fafin C, Vigneau C. [Description of characteristics, therapy and outcome of patients older than 75 years presenting with severe renal insufficiency (eGFR below 20 mL/min/1.73 m(2): pilot study]. Nephrol Ther. 2012 Dec;8(7):516-20. doi: 10.1016/j.nephro.2012.03.008. Epub 2012 Apr 27. French.

  PMID: 22542790 BACKGROUND

• Roux-Marson C, Baranski JB, Fafin C, Exterman G, Vigneau C, Couchoud C, Moranne O, Investigators PSPA. Medication burden and inappropriate prescription risk among elderly with advanced chronic kidney disease. BMC Geriatr. 2020 Mar 4;20(1):87. doi: 10.1186/s12877-020-1485-4.

  PMID: 32131742 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; 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

• Olivier Moranne, MD, PhD

  CHU de Nîmes - Service de Néphrologie Place du Pr Robert Debré 30029 Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: September 22, 2016
• Study Start: November 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2015
• Last Updated: September 27, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share