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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Fudan University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT01118494
First received: April 26, 2010
Last updated: May 5, 2010
Last verified: April 2010

April 26, 2010
May 5, 2010
September 2009
February 2010   (final data collection date for primary outcome measure)
Urinary AGT level [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Urinary AGT level can be an early bio-marker of intrarenal RAS activation and prewarning the deterioration of renal function.
Same as current
Complete list of historical versions of study NCT01118494 on ClinicalTrials.gov Archive Site
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Study of Urinary Angiotensinogen as a Marker to Warn the Deterioration of Renal Function in CKD Patients Early.
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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.

  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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

serum plasma urine supernatant urine sediment

Non-Probability Sample

CKD(chronic kidney disease),in the stage of 3 or 4.

  • Chronic Kidney Disease
  • Urinary Angiotensinogen
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CKD patients
People who have been diagnosed with CKD,and been in the stage of 3 or 4.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
June 2011
February 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years to 80 Years
No
Contact: Yong Gu, doctor 13916322128 yonggu@vip.163.com
China
 
NCT01118494
08dz1900603
Yes
HuaShan Hospital of Fudan University, Nephrology Department
Fudan University
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Fudan University
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP