Evaluation of New Markers to Assess Kidney Function

NCT00938561 | Withdrawn

• 2 other identifiers: IRB # 86082008-08
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Kidney Disease

Keywords

Chronic Kidney Disease; Glomerular Filtration Rate; Kidney function; Markers

Outcome Measures

Primary Outcomes (1)

• Accuracy and precision of the different markers for measuring GFR

  End points are not applicable. It's a cross-sectional design study

Study Arms (1)

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

Interventions

Inulin DRUG

With and without Chronic Kidney Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tufts Medical Center: lead
• Dialysis Clinic, Inc.: collaborator

Biospecimen

Blood and urine will be retained for future testing

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Inulin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides

Study Officials

• Lesley A Stevens, MD, MS

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2009
• First Posted: July 14, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2011
• Last Updated: July 13, 2016

Record last verified: 2016-07