Decline in Renal FunctionNCT01279460
Aortic Stiffness in Chronic Kidney Disease Stage 2 to 4
An observational study of Decline in Renal Function, run by Technical University of Munich at 2 sites in Germany.
Trial summary
This study aimed to investigate in a cohort with chronic kidney disease the longitudinal relationship between aortic stiffness and renal function and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Decline in Renal Function
- Type of treatment
- Injection or infusion
- How many people
- 167 participants
- Where
- 2 sitesGermany
- Study dates
- Oct 2007to Dec 2010
- 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 were enrolled in a prospective study of vascular stiffness and CV risk in patients with CKD stages 2 to 4. They were predominantly recruited from outpatients attending nephrology clinics at the Klinikum rechts der Isar der Technischen Universität München and at a private nephrological clinic in Weissenburg October 2007 to December 2008.
Who may be able to join
- Age 18 or older
- CKD 2-4
Who cannot join
- pregnancy
- history of malignant disease with a prognostic life expectancy less than 24 months
- missing of written and informed consent
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Klinikum rechts der Isar
München, Bavaria, 81675
Klinikum Weissenburg
Weißenburg in Bayern, Bavaria, 91781
About this study
Official title: Evaluation of Aortic Stiffness in CKD II to IV
This study aimed to investigate in a cohort with chronic kidney disease the longitudinal relationship between aortic stiffness and renal function and mortality.
- Conditions
- Decline in Renal Function
- Keywords
- chronic kidney disease, CKD, pulse wave velocity, PWV
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CKD Cohort of patients with renal insufficiency | patients with renal insufficiency grade II-IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
combined renal end-point (>25% decline in renal function or start of renal replacement therapy)
Measured: 24 months
Secondary outcomes (1)
mortality
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startOct 2007
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Decline in Renal FunctionStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe 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
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Nephrology, Klinikum rechts der Isar, München
- Investigators
- Marcus Baumann, M.D. PhD, Principal investigator, Klinikum rechts der Isar of the Technical University Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01279460
- Sponsor's protocol ID
- Munich-CKD-PWA
- Status last verified
- Jan 2011
- First submitted
- 17 Jan 2011
- Last updated
- 19 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Pan CR, Roos M, Schmaderer C, Lutz J, Wang JG, Heemann U, Baumann M. Interrelationship between aortic stiffness and proteinuria in chronic kidney disease. J Hum Hypertens. 2010 Sep;24(9):593-9. doi: 10.1038/jhh.2009.108. Epub 2010 Jan 28.
PubMed 20107490Townsend RR, Wimmer NJ, Chirinos JA, Parsa A, Weir M, Perumal K, Lash JP, Chen J, Steigerwalt SP, Flack J, Go AS, Rafey M, Rahman M, Sheridan A, Gadegbeku CA, Robinson NA, Joffe M. Aortic PWV in chronic kidney disease: a CRIC ancillary study. Am J Hypertens. 2010 Mar;23(3):282-9. doi: 10.1038/ajh.2009.240. Epub 2009 Dec 17.
PubMed 20019670
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Aortic Stiffness in CKD II to IV
- ClinicalTrials.gov ID
- NCT01279460
- Acronym / sponsor ID
- Munich-CKD-PWA
- Conditions
- Decline in Renal Function
- Keywords
- chronic kidney disease, CKD, pulse wave velocity, PWV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Department of Nephrology, Klinikum rechts der Isar, München
- Study start
- Oct 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 19 Jan 2011 (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.
This study aimed to investigate in a cohort with chronic kidney disease the longitudinal relationship between aortic stiffness and renal function and mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CKD Cohort of patients with renal insufficiency | – | –patients with renal insufficiency grade II-IV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were enrolled in a prospective study of vascular stiffness and CV risk in patients with CKD stages 2 to 4. They were predominantly recruited from outpatients attending nephrology clinics at the Klinikum rechts der Isar der Technischen Universität München and at a private nephrological clinic in Weissenburg October 2007 to December 2008.
Key inclusion criteria (2 listed)
- Age 18 or older
- CKD 2-4
Key exclusion criteria (3 listed)
- pregnancy
- history of malignant disease with a prognostic life expectancy less than 24 months
- missing of written and informed consent
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
combined renal end-point (>25% decline in renal function or start of renal replacement therapy)
Time frame: 24 months
1 secondary outcome
mortality
Time frame: 24 months
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 19 Jan 2011.
- Background: PubMed 20107490Pan CR, Roos M, Schmaderer C, Lutz J, Wang JG, Heemann U, Baumann M. Interrelationship between aortic stiffness and proteinuria in chronic kidney disease. J Hum Hypertens. 2010 Sep;24(9):593-9. doi: 10.1038/jhh.2009.108. Epub 2010 Jan 28.
- Background: PubMed 20019670Townsend RR, Wimmer NJ, Chirinos JA, Parsa A, Weir M, Perumal K, Lash JP, Chen J, Steigerwalt SP, Flack J, Go AS, Rafey M, Rahman M, Sheridan A, Gadegbeku CA, Robinson NA, Joffe M. Aortic PWV in chronic kidney disease: a CRIC ancillary study. Am J Hypertens. 2010 Mar;23(3):282-9. doi: 10.1038/ajh.2009.240. Epub 2009 Dec 17.
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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.
Marcus Baumann, M.D. PhD principal investigator
Klinikum rechts der Isar of the Technical University Munich
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Decline in Renal Function, run by Technical University of Munich at 2 sites 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 2 inclusion and 3 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 19 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
combined renal end-point (>25% decline in renal function or start of renal replacement therapy) (time frame: 24 months). 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 NCT01279460, which also lists 2 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 19 Jan 2011.