Assessment of Renal Physiology by Magnetic Resonance Imaging (MRI) in Normal Volunteers

Glomerular Filtration Rate Clinical Trial

Official title:

Assessment of Renal Physiology (Glomerular Filtration Rate and Blood Flow) by MRI With Validation by Inulin and Para-Aminohippuric Acid Clearance in Normal Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00936416
• Other study ID #: UHN09-0096B
• Status: Completed
• Phase: N/A
• First received: July 8, 2009
• Last updated: January 13, 2012
• Start date: January 2010
• Est. completion date: December 2011

Study information

• Verified date: January 2012
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Estimation of Glomerular Filtration Rate (GFR) is the primary test used to assess patients with renal disease. Although serum creatinine based GFR and nuclear medicine based estimations are routinely used in clinical practice, GFR estimation by Inulin is the recommended gold standard. Inulin based estimation of GFR is cumbersome and time consuming.

A decrease in blood flow to the kidney (Renal Blood Flow (RBF)) is known to cause a decrease in GFR. RBF is typically determined using radioactive tracers, contrast MRI or a cumbersome para-aminohippuric acid (PAH) clearance method.

MRI based assessment of GFR and RBF have been suggested to provide reasonable accuracy. Most of these studies did not compare the GFR and RBF estimation directly to Inulin and PAH clearance which are ther gold standards . In this study we propose to estimate MRI based GFR estimation directly to Inulin and noncontrast MRI based derived RBF to PAH to assess if MRI is an accurate test of kidney function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy male or female volunteers with no known renal disease

• Ages between 18-65 years

• Normal routine urinalysis

• Estimated GFR (eGFR) >=90mls/min

• Arterial pressure < 130/85

• No medications (birth control pills and vitamins are acceptable)

Exclusion Criteria:

• Pregnancy

• Age <18y or >65y

• Proteinuria or hematuria as determined by routine urinalysis

• Estimate GFR (eGFR) < 90 ml/min

• Known history or requirement of treatment for hypertension

• Known allergy to inulin or PAH

• MRI contrast allergy, general contraindications to MRI such as pacemaker, etc.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Glomerular Filtration Rate
• Renal Blood Flow

Intervention

Procedure:
• Inulin and PAH clearance and MRI
GFR and renal blood flow estimation by Inulin and PAH clearance will be performed in the Renal Physiology Lab for approximately 2.5 hours; The MRI test will be performed afterwards at Medical Imaging department and last about 45 minutes.

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GFR estimation comparison between results obtained by MRI and Inulin clearance method. Blood flow estimation comparison between results obtained by MRI and PAH clearance method.		1 year	No