Viewing Study NCT01118494



Ignite Creation Date: 2024-05-05 @ 10:28 PM
Last Modification Date: 2024-10-26 @ 10:19 AM
Study NCT ID: NCT01118494
Status: UNKNOWN
Last Update Posted: 2010-05-06
First Post: 2010-04-26

Brief Title: Study of Urinary Angiotensinogen as a Marker to Warn the Deterioration of Renal Function in CKD Patients Early
Sponsor: Fudan University
Organization: Fudan University

Study Overview

Official Title: None
Status: UNKNOWN
Status Verified Date: 2010-04
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 eGFRevaluated glomerular filtration ratecan 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 recognizedAbundant 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 AngiotensinogenAGT 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
Detailed Description: 1 Screening Select CKD3-4 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 patients 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None