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Study of Urinary Angiotensinogen as a Marker to Warn the Deterioration of Renal Function in CKD Patients Early.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01118494
Recruitment Status : Unknown
Verified April 2010 by Fudan University.
Recruitment status was:  Recruiting
First Posted : May 6, 2010
Last Update Posted : May 6, 2010
Information provided by:
Fudan University

Brief Summary:
Chronic kidney disease (CKD) that results in end-stage renal disease (ESRD) is a major international health problem. Many clinical markers such as urine protein or eGFR(evaluated glomerular filtration rate),can estimate the renal function, but not sensitive. As well-known, the crucial role of angiotensin II (AngII), the major effector of the renin-angiotensin system (RAS), in the development of renal fibrosis that results in ESRD is widely recognized.Abundant researches find that intrarenal RAS takes an important role on the progression of CKD. At present, no clinical marker is available to evaluate intrarenal AngII activity because it is difficult to measure it directly in patients. So find and establish a bio-marker of local renal RAS activation maybe a breakthrough in early detection and treatment of CKD. Angiotensinogen(AGT) is the only known substrate for renin and the level of AGT in humans is close to Km value for renin. Thus , changes in AGT levels can control the activity of the RAS, and its up-regulation may lead to activity of Ang levels. Then we hypothesis that the AGT is a early bio-marker of local renal RAS activation as well as CKD.

Condition or disease
Chronic Kidney Disease Urinary Angiotensinogen

Detailed Description:
  1. Screening: Select CKD(3-4) patients from outpatients, Urine routine examination and Renal B-mode ultrasonography and so on.
  2. Confirm: Sign consent with the patients who meet the inclusion criteria, then these patients are included in the study.
  3. Create patients records and complete related-inspections.
  4. Clinical follow-up: Follow-up once every six months, and we will record every patient's disease progress every time. Each follow-up, the patient needs to leave 5 ml blood samples and 20 ml of urine samples, used for the following study.
  5. Detection, Observation and Evaluation: Patients are divided into two groups according to AGT levels: higher than the normal group and the normal group. Observe the changes in eGFR of different group. Statistics judge whether AGT can be as a early warning indicators of renal function decline.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : September 2009
Estimated Primary Completion Date : February 2010
Estimated Study Completion Date : June 2011

CKD patients
People who have been diagnosed with CKD,and been in the stage of 3 or 4.

Primary Outcome Measures :
  1. Urinary AGT level [ Time Frame: 12 months ]
    Urinary AGT level can be an early bio-marker of intrarenal RAS activation and prewarning the deterioration of renal function.

Biospecimen Retention:   Samples With DNA
serum plasma urine supernatant urine sediment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
CKD(chronic kidney disease),in the stage of 3 or 4.

Inclusion Criteria:

  • CKD, in the stage of 3 or 4, and kidney biopsy is preferred selection;
  • Signed the informed consent;

Exclusion Criteria:

  • Kidney cancer patients;
  • Kidney transplantation;
  • Hereditary kidney disease;
  • Secondary renal disease(diabetic nephropathy and hypertensive nephropathy are excluded)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01118494

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Contact: Yong Gu, doctor 13916322128

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China, Shanghai
Nephrology Department of Huashan Hospital Recruiting
Shanghai, Shanghai, China, 200042
Contact: Yong Gu, Doctor    13916322128   
Sponsors and Collaborators
Fudan University
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Responsible Party: HuaShan Hospital of Fudan University, Nephrology Department Identifier: NCT01118494    
Other Study ID Numbers: 08dz1900603
First Posted: May 6, 2010    Key Record Dates
Last Update Posted: May 6, 2010
Last Verified: April 2010
Keywords provided by Fudan University:
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency