Status:
WITHDRAWN
Evaluation of New Markers to Assess Kidney Function
Lead Sponsor:
Tufts Medical Center
Collaborating Sponsors:
Dialysis Clinic, Inc.
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Brief 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...
Detailed Description
General description: The overall study procedure requires assessment of eligibility and safety for inclusion in the study through a) the screening questionnaire; b) medical history, which will be deri...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00938561
Start Date
September 1 2009
End Date
September 1 2011
Last Update
July 13 2016
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