Comparison of Markers of Kidney Function

NCT01403766 | Completed

• 1 other identifier: Gentian-Cystatin-UCLA
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

Glomerular filtration rate (GFR) is the best known measurement of kidney function. Serum creatinine (blood test) is the most commonly used marker to predict GFR. It is a convenient, inexpensive test that involves a single blood draw with rapid results. However, creatinine has several limitations because its blood level is dependent on age, body mass, and sex. One of the gold standards for measuring GFR is plasma clearance of an IV injected agent, iohexol. It has been found to be safe and nontoxic in prior studies, but is not practical in the clinical setting due to the need for several timed blood draws. Recent studies have investigated the use of cystatin C as an alternative marker to predict GFR. Cystatin C also involves only a single blood draw, and has less confounding factors than creatinine since it is independent of age, body mass, and sex. Currently, it remains controversial whether cystatin C is a significantly better biomarker of estimated GFR than creatinine. To date, there has not been a large prospective cohort study to compare cystatin C and creatinine in pediatric kidney transplant patients who are on maintenance immunosuppression (anti-rejection drugs). Accurate measurement and early detection of deterioration of GFR is critical in the care of this patient population. The purpose of this study is to assess the accuracy of estimating GFR by using cystatin C versus creatinine clearance equations when compared to the surrogate gold standard of iohexol GFR in pediatric renal transplant patients.

Conditions

Chronic Kidney Disease; Renal Insufficiency

Keywords

pediatric; kidney; transplant; GFR; creatinine; cystatin C; iohexol

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is a comparison of determination of GFR through three methods: cystatin C (Gentian assay), creatinine (Schwartz and update Schwartz) and iohexol disappearance

  Participants will be followed for the duration of the Iohexol GFR measurement (approximately 8 hours) that will take place at the time of surveillance biopsy at either 6 months, 1 or 2 years post-transplant..

Study Arms (1)

Pediatric post-kidney transplant

Patients having standard of care surviellance biopsies.

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from UCLA pediatric kidney transplant patients with stable allograft function that come in for routine surveillance biopsy. Patients will be induced with either daclizumab, basiliximab, or thymoglobulin and maintained on tacrolimus, mycophenolate mofetil, and steroid-free or steroid-based immunosuppression.

You may qualify if:

• Renal transplant patient aged 1 to \<19 years old
• Stable allograft function (no history of biopsy proven acute rejection or increase of creatinine of \> 10% from baseline in the past 6 months)
• No changes in maintenance immunosuppression in the month before the protocol biopsy
• Subject and/or parent must be able to understand and provide informed consent

You may not qualify if:

• Biopsy proven acute rejection in the past 6 months
• Change in maintenance immunosuppression in the month before the protocol biopsy
• Known diabetes mellitus
• Known thyroid dysfunction
• Allergy to Iohexol or other contrast media
• Inability or unwillingness of a participant or their legal guardian to give written informed consent or comply with the study protocol

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Gentian: collaborator

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Renal Insufficiency

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: July 25, 2011
• First Posted: July 27, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 17, 2020

Record last verified: 2020-11

Locations

US (1)