Validation of Serum Creatinine Dosage and Renal Clearance

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

Belgium

Study Type

Interventional

Intervention

Calculation of inuline clearance

Measuring serum creatinine

About this trial

This is an interventional diagnostic trial for Kidney Failure

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Normal weight as defined by a Body Mass Index of 18 to 30 kg/m2. Subject is competent and willing to sign informed consent form after being given all the detailed information about the study. Informed consent form signed voluntarily. The subjects must be in stable clinical condition, with stable serum creatinin at least for 6 months. Persons with different stage of chronic renal disease and without kidney disease (living donors) who need an evaluation of the GFR or Admitted volunteers who easily obtain urine samples. Exclusion Criteria: Transplant patients Medication that will influence the serumcreatinine. Morbid obesity Pregnant, lactating females or females with childbearing potential without adequate contraception (use of oral contraceptives, IUD or condoms with spermicide). History of allergy or hypersensitivity to inulin Donation of blood in the 60 days preceding the first visit. Liver disease, heart failure, nephrotic syndrome. Patients in critically ill conditions. Malnutrition Postrenal kidney failure

Sites / Locations

Algemeen Stedelijk Ziekenhuis Aalst
University Hospital Ghent

Outcomes

Primary Outcome Measures

Glomerular filtration ratio

Serum creatinine

Secondary Outcome Measures

Full Information

NCT ID

NCT00323128

First Posted

May 8, 2006

Last Updated

June 1, 2011

Sponsor

University Hospital, Ghent

1. Study Identification

Unique Protocol Identification Number

NCT00323128

Brief Title

Validation of Serum Creatinine Dosage and Renal Clearance

Official Title

Validation of Serum Creatinine Dosage and Renal Clearance

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Completed

Study Start Date

May 2006 (undefined)

Primary Completion Date

April 2008 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Ghent

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

This study has an open study design. The GFR will be measured using the renal clearance of inulin (Inutest) in volunteers with different stage of renal disease or without renal disease. A blood sample will be obtained for measuring serum creatinine in different laboratories.

Detailed Description

In this study we will investigate the correlation between the GFR as measured by inulin clearance (golden standard) and the estimated GFR as measured by laboratories which used different serum creatinine assays in patients without renal disease and in patients with different stage of kidney failure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Failure

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Calculation of inuline clearance

Intervention Description

Calculation of inuline clearance.

Intervention Type

Procedure

Intervention Name(s)

Measuring serum creatinine

Intervention Description

Measuring serum creatinine.

Primary Outcome Measure Information:

Title

Glomerular filtration ratio

Time Frame

At time T0

Title

Serum creatinine

Time Frame

At time T0

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Normal weight as defined by a Body Mass Index of 18 to 30 kg/m2. Subject is competent and willing to sign informed consent form after being given all the detailed information about the study. Informed consent form signed voluntarily. The subjects must be in stable clinical condition, with stable serum creatinin at least for 6 months. Persons with different stage of chronic renal disease and without kidney disease (living donors) who need an evaluation of the GFR or Admitted volunteers who easily obtain urine samples. Exclusion Criteria: Transplant patients Medication that will influence the serumcreatinine. Morbid obesity Pregnant, lactating females or females with childbearing potential without adequate contraception (use of oral contraceptives, IUD or condoms with spermicide). History of allergy or hypersensitivity to inulin Donation of blood in the 60 days preceding the first visit. Liver disease, heart failure, nephrotic syndrome. Patients in critically ill conditions. Malnutrition Postrenal kidney failure

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Raymond Van Holder, MD, PhD

Organizational Affiliation

University Hospital, Ghent

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Arjan Van der Tol, MD

Organizational Affiliation

University Hospital, Ghent

Official's Role

Principal Investigator

Facility Information:

Facility Name

Algemeen Stedelijk Ziekenhuis Aalst

City

Aalst

Country

Belgium

Facility Name

University Hospital Ghent

City

Ghent

ZIP/Postal Code

9000

Country

Belgium

12. IPD Sharing Statement

Links:

URL

http://www.uzgent.be

Description

Website University Hospital Ghent

Kidney Failure

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial