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

Chronic Kidney Disease Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01118494
• Other study ID #: 08dz1900603
• Status: Recruiting
• Phase: N/A
• First received: April 26, 2010
• Last updated: May 5, 2010
• Start date: September 2009
• Est. completion date: June 2011

Study information

• Verified date: April 2010
• Source: Fudan University
• Contact: Yong Gu, doctor
• Phone: 13916322128
• Email: yonggu[@]vip.163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 2011
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic
• Urinary Angiotensinogen

Locations

Country	Name	City	State
China	Nephrology Department of Huashan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary AGT level	Urinary AGT level can be an early bio-marker of intrarenal RAS activation and prewarning the deterioration of renal function.	12 months	No