Validation of Serum Creatinine Dosage and Renal Clearance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Kidney Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Calculation of inuline clearance

Calculation of inuline clearance.

Intervention Type PROCEDURE

Measuring serum creatinine

Measuring serum creatinine.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No