Evaluation of New Markers to Assess Kidney Function - Full Text View

Sponsor:	Tufts Medical Center
Collaborator:	Dialysis Clinic, Inc.
Information provided by:	Tufts Medical Center
ClinicalTrials.gov Identifier:	NCT00938561

Purpose

Glomerular filtration rate (GFR) is widely accepted as the best index of kidney function in health and disease, and accurate values are required for optimal clinical decision making and in large-scale epidemiologic studies and clinical trials. Current recommended methods for measuring GFR are expensive, cumbersome to administer and assay and requires urine collection and administration of radioactive materials. The purpose of this study is to evaluate two non-radioactive markers (iohexol and gadolinium) compared to urinary clearance of inulin and iothalamate. The investigators hypothesize that plasma clearance of non-radioactive markers will be unbiased compared to a gold standard and more precise than currently used urinary clearance methods.

Condition
Chronic Kidney Disease

Study Type:	Observational
Study Design:	Observational Model: Cohort
Official Title:	Validity and Reliability of a Novel GFR Marker

Resource links provided by NLM:

MedlinePlus related topics: Chronic Kidney Disease Kidney Failure

U.S. FDA Resources

Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:

Accuracy and precision of the different markers for measuring GFR [ Time Frame: End points are not applicable. It's a cross-sectional design study ] [ Designated as safety issue: No ]

Biospecimen Description:

Blood and urine will be retained for future testing

Estimated Enrollment:	25
Study Start Date:	September 2009
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
With and without Chronic Kidney Disease A cohort of 10 patients subjects with and without kidney disease exhibiting a broad range of age and kidney function

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Subjects with CKD and without CKD will be recruited to participate in the study. Subjects with CKD will be recruited primarily from the Kidney and Blood Pressure Center. Subjects without CKD will be recruited from advertisements as well as the volunteer database at the Jean Mayer Human Nutrition Research Center on Aging (HRNCA), which is located next to Tufts Medical Center.

Criteria

Inclusion Criteria:

Male or female.
Older than 18 years of age.
With and without known CKD - for the purpose of this study, CKD will be defined on the basis by prior diagnosis of CKD, urologic or kidney disease, known abnormal urinalysis, or history of having seen a nephrologist.

Exclusion Criteria:

Currently undergoing or having received peritoneal dialysis or hemodialysis treatment within the past three months. Subjects with an eGFR < 30 mL/min/1.73 m2 will not receive Magnevist during the study visit.
Active pulmonary edema.
Class III or IV congestive heart failure.
History of urinary retention or current urinary incontinence.
Inability to cease taking medications that affect creatinine levels (e.g., bactrim, cimetidine) for one week prior to the study visit.
Inability to maintain a stable regimen of anti-inflammatory agents and angiotensin converting enzyme inhibitors for one week prior to study visit
Current treatment with amiodarone or metformin.
Acute exacerbation of asthma or chronic obstructive lung disease in the past three months requiring hospitalization or oral steroid therapy.
Inadequate venous access.
End stage conditions such as cirrhosis.
Active treatment for cancer.
Progressive neurological diseases.
Severe gastric immotility.
Recent radiation exposure to γ-emitting isotope other than technetium
Known allergy to any of the GFR markers, iodine, or shellfish. Subjects who are not sure if they have an iodine allergy because they have not eaten shellfish or have never received contrast dye will be excluded from participation.
Dermatitis herpetiformis.
Hypocomplementemic vasculitis.
Multinodal goiter.
Graves' disease.
Autoimmune thyroiditis.
Cognitive or physical impairments that will prevent a subject from providing informed consent.
History of mastectomy.
Hemoglobin levels below 10 g/dL.
Women who are either pregnant or who intend to become pregnant during the period of time in which the study visits will occur.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00938561

Contacts

Contact: Aghogho Okparavero, MBBS, MPH	617-636-3043	aokparavero@tuftsmedicalcenter.org
Contact: Lesley Stevens, MS MD	617-636-2569	lstevens1@tuftsmedicalcenter.org

Locations

United States, Massachusetts
Tufts Medical Center	Recruiting
Boston, Massachusetts, United States, 02111

Sponsors and Collaborators

Tufts Medical Center

Dialysis Clinic, Inc.

Investigators

Principal Investigator:

Lesley A Stevens, MD, MS

Tufts Medical Center

More Information

No publications provided

Responsible Party:	Lesley Stevens MD, MS/ Assistant Professor of Medicine, Tufts Medical Center
ClinicalTrials.gov Identifier:	NCT00938561 History of Changes
Other Study ID Numbers:	IRB # 8608, 2008-08
Study First Received:	July 8, 2009
Last Updated:	May 19, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Tufts Medical Center:

Chronic Kidney Disease
Glomerular Filtration Rate
Kidney function
Markers

Additional relevant MeSH terms:

Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on May 23, 2012