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Aortic Stiffness in Chronic Kidney Disease Stage 2 to 4

This study has been completed.
Sponsor:
Collaborator:
Department of Nephrology, Klinikum rechts der Isar, München
Information provided by:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01279460
First received: January 17, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

This study aimed to investigate in a cohort with chronic kidney disease the longitudinal relationship between aortic stiffness and renal function and mortality.


Condition
Decline in Renal Function

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Aortic Stiffness in CKD II to IV

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • combined renal end-point (>25% decline in renal function or start of renal replacement therapy) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mortality [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 167
Study Start Date: October 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
CKD Cohort of patients with renal insufficiency
patients with renal insufficiency grade II-IV

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • Age 18 or older
  • CKD 2-4

Exclusion Criteria:

  • pregnancy
  • history of malignant disease with a prognostic life expectancy less than 24 months
  • missing of written and informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01279460

Locations
Germany
Klinikum rechts der Isar
München, Bavaria, Germany, 81675
Klinikum Weissenburg
Weissenburg, Bavaria, Germany, 91781
Sponsors and Collaborators
Technische Universität München
Department of Nephrology, Klinikum rechts der Isar, München
Investigators
Principal Investigator: Marcus Baumann, M.D. PhD Klinikum rechts der Isar of the Technical University Munich
  More Information

Publications:
Responsible Party: PD. Dr. med. Marcus Baumann, M.D., PhD, Technical University of Munich, Klinikum rechts der Isar, Department of nephrology
ClinicalTrials.gov Identifier: NCT01279460     History of Changes
Other Study ID Numbers: Munich-CKD-PWA
Study First Received: January 17, 2011
Last Updated: January 17, 2011
Health Authority: Ethikkommission der Fakultät für Medizin der Technischen Universität München, Germany:

Keywords provided by Technische Universität München:
chronic kidney disease
CKD
pulse wave velocity
PWV

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on November 27, 2014