Comparison of Markers of Kidney Function

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by University of California, Los Angeles.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Gentian
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01403766
First received: July 25, 2011
Last updated: July 26, 2011
Last verified: July 2011
  Purpose

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.


Condition
Chronic Kidney Disease
Renal Insufficiency

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Estimated GFR Using Cystatin C Versus Creatinine in Pediatric Renal Transplant Patients

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • 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.. ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: August 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pediatric post-kidney transplant
Patients having standard of care surviellance biopsies.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01403766

Contacts
Contact: Eileen Tsai, M.D. (310) 206-6987 etsai@mednet.ucla.edu
Contact: Margaret Holloway, R.N. (310) 206-8415 mholloway@mednet.ucla.edu

Locations
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    etsai@mednet.ucla.edu   
Principal Investigator: Eileen Tsai, M.D.         
Sub-Investigator: John Nguyen, M.D.         
Sponsors and Collaborators
University of California, Los Angeles
Gentian
  More Information

No publications provided

Responsible Party: Eileen Tsai, M.D., University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01403766     History of Changes
Other Study ID Numbers: Gentian-Cystatin-UCLA
Study First Received: July 25, 2011
Last Updated: July 26, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
pediatric
kidney
transplant
GFR
creatinine
cystatin C
iohexol

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014