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Evaluation of New Markers to Assess Kidney Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00938561
Recruitment Status : Withdrawn (Non availability of funding)
First Posted : July 14, 2009
Last Update Posted : July 13, 2016
Dialysis Clinic, Inc.
Information provided by (Responsible Party):
Tufts Medical Center

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 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 or disease Intervention/treatment
Chronic Kidney Disease Drug: Inulin

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Official Title: Validity and Reliability of a Novel GFR Marker
Study Start Date : September 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Inulin

Group/Cohort Intervention/treatment
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
Drug: Inulin

Primary Outcome Measures :
  1. Accuracy and precision of the different markers for measuring GFR [ Time Frame: End points are not applicable. It's a cross-sectional design study ]

Biospecimen Description:
Blood and urine will be retained for future testing

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00938561

Sponsors and Collaborators
Tufts Medical Center
Dialysis Clinic, Inc.
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Principal Investigator: Lesley A Stevens, MD, MS Tufts Medical Center
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Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00938561    
Other Study ID Numbers: IRB # 8608
First Posted: July 14, 2009    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016
Keywords provided by Tufts Medical Center:
Chronic Kidney Disease
Glomerular Filtration Rate
Kidney function
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency