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
  Purpose

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
Chronic Kidney Disease
Urinary Angiotensinogen

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA

serum plasma urine supernatant urine sediment


Estimated Enrollment: 400
Study Start Date: September 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
CKD patients
People who have been diagnosed with CKD,and been in the stage of 3 or 4.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01118494

Contacts
Contact: Yong Gu, doctor 13916322128 yonggu@vip.163.com

Locations
China, Shanghai
Nephrology Department of Huashan Hospital Recruiting
Shanghai, Shanghai, China, 200042
Contact: Yong Gu, Doctor    13916322128    yonggu@vip.163.com   
Sponsors and Collaborators
Fudan University
  More Information

No publications provided

Responsible Party: HuaShan Hospital of Fudan University, Nephrology Department
ClinicalTrials.gov Identifier: NCT01118494     History of Changes
Other Study ID Numbers: 08dz1900603
Study First Received: April 26, 2010
Last Updated: May 5, 2010
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
CKD
RAS
AGT

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

ClinicalTrials.gov processed this record on April 17, 2014