Comparison of Markers of Kidney Function
|ClinicalTrials.gov Identifier: NCT01403766|
Recruitment Status : Unknown
Verified July 2011 by University of California, Los Angeles.
Recruitment status was: Not yet recruiting
First Posted : July 27, 2011
Last Update Posted : July 27, 2011
|Condition or disease|
|Chronic Kidney Disease Renal Insufficiency|
Study patients will come in for their surveillance biopsy done as standard of care post-transplant. They we be made NPO at midnight prior to the biopsy per routine. On arrival, they will have standard of care pre-biopsy bloods drawn along with baseline study labs including serum enzymatic creatinine (1mL of blood), cystatin C (1.5 mL of blood), and 1mL of blood collected pre-iohexol infusion. Two IV's will be started, one for iohexol administration and fluids, and the other for blood draws. Study patients will be started on 1x maintenance intravenous fluids. The patient will then have their standard of care protocol biopsy in the ultrasound suite. After the biopsy 5 mL Iohexol (Omnipaque 300) will be administered over 1-2 minutes, with epinephrine, solumedrol, and diphenhydramine on hand in the event of a reaction although this is very unlikely. The patient will be observed and vital signs will be taken 10 minutes post-infusion. After biopsy, maintenance fluids will be continued until completion of the study. Blood for determination of Iohexol levels (1mL) will be drawn at 10, 30, 120, and 300 minutes post iohexol infusion when patient is being observed post biopsy. At completion of the study at 300 minutes post iohexol infusion, serum creatinine (1mL of blood), cystatin C (1.5 mL of blood) will be drawn again. The total volume of blood drawn for the study will be 10mL.
Creatinine (enzymatic method) will be determined on the Olympus system, and Cystatin C (Gentian assay) will be determined on the AU400 Olympus System at the UCLA Department of Pathology and Laboratory Medicine Outreach Laboratory. Iohexol GFR will be determined at the University of Rochester Medical Center in Dr. Schwartz's laboratory. Kidney biopsies will be graded by updated Banff criteria, and reviewed by blinded pathologist.
|Study Type :||Observational|
|Estimated Enrollment :||70 participants|
|Official Title:||Comparison of Estimated GFR Using Cystatin C Versus Creatinine in Pediatric Renal Transplant Patients|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||December 2012|
Pediatric post-kidney transplant
Patients having standard of care surviellance biopsies.
- 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 [ Time Frame: 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.. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01403766
|Contact: Eileen Tsai, M.D.||(310) email@example.com|
|Contact: Margaret Holloway, R.N.||(310) firstname.lastname@example.org|
|United States, California|
|University of California, Los Angeles||Not yet recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Eileen Tsai, M.D. 310-206-8415 email@example.com|
|Principal Investigator: Eileen Tsai, M.D.|
|Sub-Investigator: John Nguyen, M.D.|