Kidney Failure, ChronicPSPANCT02910908
Characteristics,Treatment Course and Prognosis of Patients Older Than 75 Yrs Old Reaching End Stage Renal Disease (PSPA)
An observational study of Kidney Failure, Chronic, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Kidney Failure, Chronic
- How many people
- 581 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2009to Nov 2015
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients follow by nephrologist with CKD and eGFR less than 20 mL/min/1.73 m2 (estimated by sMDRD formula)
Who may be able to join
- Patients were age older than 75 > years,
- Chronic Kidney Disease with eGFR less than 20 mL/min/1.73 m2 (estimated by sMDRD formula)
Who cannot join
- Acute renal failure and late referral defined by dialysis starting without previous nephrologist follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characteristics and Treatment Course of Patients Older Than 75 Years Old Reaching ESRD. Development of a Prognosis Tools for Early Mortality
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:
Read more
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.
Read the detailed description
At inclusion for each patient data were collected on demographic and clinical conditions (comorbidities and disabilities), mobility (walk without help, need assistance and totally dependent for transfers), way of living (home living or institutionalized), biological data (blood and urine), therapeutic projects about the option for dialysis and the medicals reason to start dialysis. As it is an observational study of current practices, no additional tests or additional visits were mandatory either at inclusion or during the follow-up.
Data on dialysis start and outcomes were extracted from the French National ESRD registry REIN. This linkage was approved by the French Advisory Committee on Information Processing in Material Research in the Field of Health (CCTIRS), the National Commission for Information Technology and Privacy (Commission Nationale de l'Informatique et des Libertes) and ethic committee. The starting dialysis condition included patient's clinical characteristics, the use of a central vascular catheter (CVC), the unplanned condition of dialysis start and the first modality of dialysis (peritoneal or hemodialysis). After dialysis start, patient survival and information about dialysis withdrawal before death was collected.
The number of patients to include was fixed to more than 500 to study at least 15 prognosis factors with estimation of more than 30% of death during follow-up.
- Conditions
- Kidney Failure, Chronic
- Keywords
- Elderly, ESRD prognosis, help decision making dialysis therapeutic project
- Medical subject headings
- Kidney Failure, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: Five years
Has dialysis started? yes/no
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startNov 2009
- Primary completionNov 2010
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 581 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Moranne, MD, PhD, Principal investigator, CHU de Nîmes - Service de Néphrologie Place du Pr Robert Debré 30029 Nîmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02910908
- Sponsor's protocol ID
- 30RC15_0144-PSPA
- Acronym
- PSPA
- Status last verified
- Jan 2016
- First submitted
- 13 Sep 2016
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 19096087Joly 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.
PubMed 12660336Hemmelgarn 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.
PubMed 22797451Moranne 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.
PubMed 22542790Roux-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.
PubMed 32131742
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics and Treatment Course of Patients Older Than 75 Years Old Reaching ESRD. Development of a Prognosis Tools for Early Mortality
- ClinicalTrials.gov ID
- NCT02910908
- Acronym / sponsor ID
- PSPA / 30RC15_0144-PSPA
- Conditions
- Kidney Failure, Chronic
- Keywords
- Elderly, ESRD prognosis, help decision making dialysis therapeutic project
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 581 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 22 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
At inclusion for each patient data were collected on demographic and clinical conditions (comorbidities and disabilities), mobility (walk without help, need assistance and totally dependent for transfers), way of living (home living or institutionalized), biological data (blood and urine), therapeutic projects about the option for dialysis and the medicals reason to start dialysis. As it is an observational study of current practices, no additional tests or additional visits were mandatory either at inclusion or during the follow-up.
Data on dialysis start and outcomes were extracted from the French National ESRD registry REIN. This linkage was approved by the French Advisory Committee on Information Processing in Material Research in the Field of Health (CCTIRS), the National Commission for Information Technology and Privacy (Commission Nationale de l'Informatique et des Libertes) and ethic committee. The starting dialysis condition included patient's clinical characteristics, the use of a central vascular catheter (CVC), the unplanned condition of dialysis start and the first modality of dialysis (peritoneal or hemodialysis). After dialysis start, patient survival and information about dialysis withdrawal before death was collected.
The number of patients to include was fixed to more than 500 to study at least 15 prognosis factors with estimation of more than 30% of death during follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients follow by nephrologist with CKD and eGFR less than 20 mL/min/1.73 m2 (estimated by sMDRD formula)
Key inclusion criteria (2 listed)
- Patients were age older than 75 > years,
- Chronic Kidney Disease with eGFR less than 20 mL/min/1.73 m2 (estimated by sMDRD formula)
Key exclusion criteria (1 listed)
- Acute renal failure and late referral defined by dialysis starting without previous nephrologist follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: Five years
Has dialysis started? yes/no
Time frame: Five years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Background: PubMed 19096087Couchoud 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.
- Background: PubMed 12660336Joly 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.
- Background: PubMed 22797451Hemmelgarn 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.
- Background: PubMed 22542790Moranne 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.
- Derived from this study: PubMed 32131742Roux-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Moranne, MD, PhD principal investigator
CHU de Nîmes - Service de Néphrologie Place du Pr Robert Debré 30029 Nîmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Failure, Chronic, run by Centre Hospitalier Universitaire de Nīmes 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 2 inclusion and 1 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 18 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?
Mortality (time frame: Five years). The study lists 2 primary outcomes in all. 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 NCT02910908, which also lists 5 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 18 Jun 2026.