Evaluation of New Markers to Assess Kidney Function

• Status: Withdrawn
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tufts Medical Center
• Collaborator: Dialysis Clinic, Inc.

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.