Complication of Renal DialysisCoDiRaGNCT03820765
Cessation of Dialysis Treatment in Reinbek and Geesthacht
An observational study of Complication of Renal Dialysis and Long-Term Disorder of Dialysis, run by University of Luebeck at 1 site in Germany.
Trial summary
Currently, approximately 80.000 patients with end stage renal disease (ESRD) in Germany undergo chronic renal replacement therapy, either as hemodialysis or peritonealdialysis. Since the nationwide registry for chronic dialysis patients (QuasiNiere) was terminated in 2006, no data exist from that time on regarding… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Complication of Renal Dialysis, Long-Term Disorder of Dialysis
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2016to 31 Jan 2020
- How long will I take part?
- 4 Years
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with the necessity of chronic renal replacement therapy
Who may be able to join
- Patients with end stage renal disease and hemodialyis or peritonealdialysis
- Renal replacement therapy performed in our centers Reinbek or Geesthacht
- at least 4 weeks of dialysis treatment in any of our two treatment sites
Who cannot join
- dialysis treatment period in our centers shorten than 4 weeks
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Nephrology Center Reinbek and Geesthacht
Reinbek, 21465
Markus Meier, MD, ++49-451-500-6406, markus.meier@uk-sh.de
Markus Meier, MD
About this study
Official title: Analysis of Cessation of the Dialysis Treatment in Reinbek-Northern Germany
Currently, approximately 80.000 patients with end stage renal disease (ESRD) in Germany undergo chronic renal replacement therapy, either as hemodialysis or peritonealdialysis. Since the nationwide registry for chronic dialysis patients (QuasiNiere) was terminated in 2006, no data exist from that time on regarding alterations in morbidity and mortality of patients with end stage renal disease in Germany.
With this study we start a single center prospective registry of all patients undergoing hemodialysis or peritonealdialysis therapy in our two nephrology departments Reinbek and Geesthacht. In these centers we perform approximately 34.000 hemodialysis sessions and supervise about 10.000 peritoneal treatment days of about 300 ESRD patients annually.
Read more
The aim of the study is to analyze all patients who stopped dialysis treatment in our centers due to death, kidney transplantation, recovery of renal function or other causes. Patients characteristics such as underlying renal diseases, duration of dialysis, co-morbidities as well as laboratory parameters will be recorded.
The data is collected with an Microsoft Access Database and analyzed by a statistician of the University of Luebeck (Germany). Power calculations revealed, that at least 200 patients were necessary to detect differences in particular interesting variables such as vascular access or the need of palliative care. During the last years at least 50 patients stopped chronic renal replacement therapy at out centers annually. Thus, the first interims evaluation is expected after 4 years.
The results of our study are important to estimate the development of patient age and renal diseases responsible for dialysis therapy in our centers. Moreover, the results may add important information to our internal quality assurance.
- Keywords
- Hemodialyis, Peritonealdialysis, Qualitiy assurance dialysis
What is being measured
The primary outcome is the main question the study is designed to answer.
Dialysis time (months) as a function of patient age (years).
Differences of the dialysis time (months) between patients < 65 years, 65-80 years and > 80 years.
Measured: 4 years
Underlying renal disease of ESRD patients
Differences of the underlying renal disease between patients with initiation of dialysis prior to 31.12.2012 or after 1.1.2013
Measured: 6 years
Secondary outcomes (1)
Albumin concentration of ESRD patients
Serum albumin concentration of dialysis patients at initiation of treatment, after 6 months and at cessation of dialysis
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start1 Jan 2016
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Complication of Renal DialysisStudies of the same condition, open and under way.
- 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
- 200 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Markus Meier, MD, University of Luebeck
- Investigators
- Markus Meier, MD, Principal investigator, University of Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03820765
- Sponsor's protocol ID
- CODIRAG-2019
- Acronym
- CoDiRaG
- Status last verified
- Jan 2019
- First submitted
- 23 Jan 2019
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McCullough K, Sharma P, Ali T, Khan I, Smith WC, MacLeod A, Black C. Measuring the population burden of chronic kidney disease: a systematic literature review of the estimated prevalence of impaired kidney function. Nephrol Dial Transplant. 2012 May;27(5):1812-21. doi: 10.1093/ndt/gfr547. Epub 2011 Sep 29.
PubMed 21965592Schober-Halstenberg HJ. End-stage renal disease in aging societies: a global perspective. J Ren Nutr. 2009 Sep;19(5 Suppl):S3-4. doi: 10.1053/j.jrn.2009.06.015. No abstract available.
PubMed 19712874Frei U, Schober-Halstenberg HJ. Annual Report of the German Renal Registry 1998. QuaSi-Niere Task Group for Quality Assurance in Renal Replacement Therapy. Nephrol Dial Transplant. 1999 May;14(5):1085-90. doi: 10.1093/ndt/14.5.1085.
PubMed 10344342Frei U. Quality assurance in renal replacement therapy (RRT)--background of a developing German National Registry for RRT. QuaSi-Niere Task Group. Nephrol Dial Transplant. 1995;10(4):442-3. doi: 10.1093/ndt/10.4.442. No abstract available.
PubMed 7623980
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Cessation of the Dialysis Treatment in Reinbek-Northern Germany
- ClinicalTrials.gov ID
- NCT03820765
- Acronym / sponsor ID
- CoDiRaG / CODIRAG-2019
- Keywords
- Hemodialyis, Peritonealdialysis, Qualitiy assurance dialysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Jan 2020 (estimated)
- First posted
- 29 Jan 2019 (actual)
- 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.
Currently, approximately 80.000 patients with end stage renal disease (ESRD) in Germany undergo chronic renal replacement therapy, either as hemodialysis or peritonealdialysis. Since the nationwide registry for chronic dialysis patients (QuasiNiere) was terminated in 2006, no data exist from that time on regarding alterations in morbidity and mortality of patients with end stage renal disease in Germany.
With this study we start a single center prospective registry of all patients undergoing hemodialysis or peritonealdialysis therapy in our two nephrology departments Reinbek and Geesthacht. In these centers we perform approximately 34.000 hemodialysis sessions and supervise about 10.000 peritoneal treatment days of about 300 ESRD patients annually.
The aim of the study is to analyze all patients who stopped dialysis treatment in our centers due to death, kidney transplantation, recovery of renal function or other causes. Patients characteristics such as underlying renal diseases, duration of dialysis, co-morbidities as well as laboratory parameters will be recorded.
The data is collected with an Microsoft Access Database and analyzed by a statistician of the University of Luebeck (Germany). Power calculations revealed, that at least 200 patients were necessary to detect differences in particular interesting variables such as vascular access or the need of palliative care. During the last years at least 50 patients stopped chronic renal replacement therapy at out centers annually. Thus, the first interims evaluation is expected after 4 years.
The results of our study are important to estimate the development of patient age and renal diseases responsible for dialysis therapy in our centers. Moreover, the results may add important information to our internal quality assurance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with the necessity of chronic renal replacement therapy
Key inclusion criteria (3 listed)
- Patients with end stage renal disease and hemodialyis or peritonealdialysis
- Renal replacement therapy performed in our centers Reinbek or Geesthacht
- at least 4 weeks of dialysis treatment in any of our two treatment sites
Key exclusion criteria (1 listed)
- dialysis treatment period in our centers shorten than 4 weeks
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
Dialysis time (months) as a function of patient age (years).
Time frame: 4 years
Differences of the dialysis time (months) between patients < 65 years, 65-80 years and > 80 years.
Underlying renal disease of ESRD patients
Time frame: 6 years
Differences of the underlying renal disease between patients with initiation of dialysis prior to 31.12.2012 or after 1.1.2013
1 secondary outcome
Albumin concentration of ESRD patients
Time frame: 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
- Results publication: PubMed 21965592McCullough K, Sharma P, Ali T, Khan I, Smith WC, MacLeod A, Black C. Measuring the population burden of chronic kidney disease: a systematic literature review of the estimated prevalence of impaired kidney function. Nephrol Dial Transplant. 2012 May;27(5):1812-21. doi: 10.1093/ndt/gfr547. Epub 2011 Sep 29.
- Results publication: PubMed 19712874Schober-Halstenberg HJ. End-stage renal disease in aging societies: a global perspective. J Ren Nutr. 2009 Sep;19(5 Suppl):S3-4. doi: 10.1053/j.jrn.2009.06.015. No abstract available.
- Results publication: PubMed 10344342Frei U, Schober-Halstenberg HJ. Annual Report of the German Renal Registry 1998. QuaSi-Niere Task Group for Quality Assurance in Renal Replacement Therapy. Nephrol Dial Transplant. 1999 May;14(5):1085-90. doi: 10.1093/ndt/14.5.1085.
- Results publication: PubMed 7623980Frei U. Quality assurance in renal replacement therapy (RRT)--background of a developing German National Registry for RRT. QuaSi-Niere Task Group. Nephrol Dial Transplant. 1995;10(4):442-3. doi: 10.1093/ndt/10.4.442. No abstract available.
- 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.
Markus Meier, MD principal investigator
University of Luebeck
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 Complication of Renal Dialysis and Long-Term Disorder of Dialysis, run by University of Luebeck at 1 site in Germany.
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 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: status not confirmed, as of the sponsor's last update on 29 Jan 2019. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Markus Meier, MD (++49-40-7277860, markus.meier@dialyse-reinbek.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dialysis time (months) as a function of patient age (years). (time frame: 4 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 NCT03820765, which also lists 4 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 29 Jan 2019.