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Status unknownNCT01118494Updated May 6, 2010

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

An observational study in Chronic Kidney Disease and Urinary Angiotensinogen, sponsored by Fudan University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-05-06.

Sponsored by Fudan University · Observational

The sponsor has not verified this record recently (last verified Apr 2010), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
400
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Chronic Kidney Disease
  • Urinary Angiotensinogen

Keywords

  • CKD
  • RAS
  • AGT
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's planned enrollment of 400 is above the median of 192 across 1,033 observational studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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

Exclusion Criteria:

  • Kidney cancer patients;
  • Kidney transplantation;
  • Hereditary kidney disease;
  • Secondary renal disease(diabetic nephropathy and hypertensive nephropathy are excluded)
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
400 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • CKD patients

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

06

What researchers measure

Primary outcomes

  1. Urinary AGT level

    Urinary AGT level can be an early bio-marker of intrarenal RAS activation and prewarning the deterioration of renal function.

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Nephrology Department of Huashan Hospital
    Shanghai, Shanghai 200042, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01118494
Lead sponsor
Fudan University
First posted
May 6, 2010
Start date
Sep 2009
Primary completion
Feb 2010 (estimated)
Completion
Jun 2011 (estimated)
Last update
May 6, 2010

Study contacts

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

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.

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