Two-Point Measurement of Glomerular Filtration Rate by Iohexol Plasma Disappearance

NCT01545531 | Completed

• 1 other identifier: 6726
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to measure glomerular filtration rate (GFR) by iohexol plasma disappearance (gold standard) and measure serum Cystatin C levels (surrogate marker) in patients enrolled in our prospective study at baseline, day 100 and 1 year after hematopoietic cell transplant and determine if these levels correlate with serum creatinine and an estimated GFR using the Modification of Diet in Renal Disease (MDRD) equation and Schwartz formula in children.

Conditions

Renal Disease; Renal Insufficiency

Keywords

glomerular filtration rate; iohexol; hematopoietic cell transplant; kidney function; gold standard measure; cystatin C.

Outcome Measures

Primary Outcomes (3)

• glomerular filtration rate

  Change from baseline in glomeular filtration rate at different time points after hematopoietic cell transplant

• Glomerular Filtration Rate (GFR)

  Change from Baseline in GFR at 80 to 100 days post transplant

• Glomerular Filtration Rate (GFR)

  Change from Baseline in GFR at 1 year post tranplant

Study Arms (1)

Iohexol GFR

Drug: Iohexol

Interventions

Iohexol DRUG

Iohexol, a non-ionic, low osmolar, X-ray contrast medium (OmnipaqueR) that is safe and non-toxic and used for angiographic and urographic procedures, is eliminated from plasma exclusively by glomerular filtration \[13\]. Study subject will receive 5 ml of iohexol solution (Omnipaque 300, corresponding to 647 mg iohexol per ml or 300 mg iodine per ml) through peripheral IV or central Line infusion over 1-2 minutes followed by 10 ml of saline solution at baseline, day 100 and 1 year after HCT.

Iohexol GFR

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing hematopoietic cell transplant

You may qualify if:

• age \> 2 years
• follow-up at Seattle cancer care alliance

You may not qualify if:

• age \<2 years
• history of diabetes mellitus
• inability to return to the SCCA for follow-up at 1 year
• allergy to iodine

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Related Publications (14)

• Beddhu S, Samore MH, Roberts MS, Stoddard GJ, Pappas LM, Cheung AK. Creatinine production, nutrition, and glomerular filtration rate estimation. J Am Soc Nephrol. 2003 Apr;14(4):1000-5. doi: 10.1097/01.asn.0000057856.88335.dd.

  PMID: 12660334 BACKGROUND

• Ross EA, Wilkinson A, Hawkins RA, Danovitch GM. The plasma creatinine concentration is not an accurate reflection of the glomerular filtration rate in stable renal transplant patients receiving cyclosporine. Am J Kidney Dis. 1987 Aug;10(2):113-7. doi: 10.1016/s0272-6386(87)80042-2.

  PMID: 3300293 BACKGROUND

• Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med. 1999 Mar 16;130(6):461-70. doi: 10.7326/0003-4819-130-6-199903160-00002.

  PMID: 10075613 BACKGROUND

• Fliser D, Franek E, Joest M, Block S, Mutschler E, Ritz E. Renal function in the elderly: impact of hypertension and cardiac function. Kidney Int. 1997 Apr;51(4):1196-204. doi: 10.1038/ki.1997.163.

  PMID: 9083286 BACKGROUND

• Levey AS, Atkins R, Coresh J, Cohen EP, Collins AJ, Eckardt KU, Nahas ME, Jaber BL, Jadoul M, Levin A, Powe NR, Rossert J, Wheeler DC, Lameire N, Eknoyan G. Chronic kidney disease as a global public health problem: approaches and initiatives - a position statement from Kidney Disease Improving Global Outcomes. Kidney Int. 2007 Aug;72(3):247-59. doi: 10.1038/sj.ki.5002343. Epub 2007 Jun 13.

  PMID: 17568785 BACKGROUND

• Dharnidharka VR, Kwon C, Stevens G. Serum cystatin C is superior to serum creatinine as a marker of kidney function: a meta-analysis. Am J Kidney Dis. 2002 Aug;40(2):221-6. doi: 10.1053/ajkd.2002.34487.

  PMID: 12148093 BACKGROUND

• Seronie-Vivien S, Toullec S, Malard L, Thomas F, Durrand V, Chatelut E. Contribution of the MDRD equation and of cystatin C for renal function estimates in cancer patients. Med Oncol. 2006;23(1):63-73. doi: 10.1385/MO:23:1:63.

  PMID: 16645231 BACKGROUND

• Visvardis G, Griveas I, Zilidou R, Papadopoulou D, Mitsopoulos E, Kyriklidou P, Manou E, Ginikopoulou E, Meimaridou D, Pavlitou A, Sakellariou G. Glomerular filtration rate estimation in renal transplant patients based on serum cystatin-C levels: comparison with other markers of glomerular filtration rate. Transplant Proc. 2004 Jul-Aug;36(6):1757-9. doi: 10.1016/j.transproceed.2004.06.009.

  PMID: 15350470 BACKGROUND

• Shlipak MG, Sarnak MJ, Katz R, Fried LF, Seliger SL, Newman AB, Siscovick DS, Stehman-Breen C. Cystatin C and the risk of death and cardiovascular events among elderly persons. N Engl J Med. 2005 May 19;352(20):2049-60. doi: 10.1056/NEJMoa043161.

  PMID: 15901858 BACKGROUND

• Al-Tonbary YA, Hammad AM, Zaghloul HM, El-Sayed HE, Abu-Hashem E. Pretreatment cystatin C in children with malignancy: can it predict chemotherapy-induced glomerular filtration rate reduction during the induction phase? J Pediatr Hematol Oncol. 2004 Jun;26(6):336-41. doi: 10.1097/00043426-200406000-00002.

  PMID: 15167345 BACKGROUND

• Holweger K, Bokemeyer C, Lipp HP. Accurate measurement of individual glomerular filtration rate in cancer patients: an ongoing challenge. J Cancer Res Clin Oncol. 2005 Sep;131(9):559-67. doi: 10.1007/s00432-005-0679-7. Epub 2005 Oct 20.

  PMID: 16012866 BACKGROUND

• Kleber M, Cybulla M, Bauchmuller K, Ihorst G, Koch B, Engelhardt M. Monitoring of renal function in cancer patients: an ongoing challenge for clinical practice. Ann Oncol. 2007 May;18(5):950-8. doi: 10.1093/annonc/mdm055. Epub 2007 Mar 9.

  PMID: 17351260 BACKGROUND

• Demirtas S, Akan O, Can M, Elmali E, Akan H. Cystatin C can be affected by nonrenal factors: a preliminary study on leukemia. Clin Biochem. 2006 Feb;39(2):115-8. doi: 10.1016/j.clinbiochem.2005.10.009. Epub 2005 Dec 6.

  PMID: 16337174 BACKGROUND

• Perkins BA, Nelson RG, Ostrander BE, Blouch KL, Krolewski AS, Myers BD, Warram JH. Detection of renal function decline in patients with diabetes and normal or elevated GFR by serial measurements of serum cystatin C concentration: results of a 4-year follow-up study. J Am Soc Nephrol. 2005 May;16(5):1404-12. doi: 10.1681/ASN.2004100854. Epub 2005 Mar 23.

  PMID: 15788478 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample for iohexol level, serum creatinine, cystatin C, and hematocrit at baseline, prior to iohexol infusion, 2 hours and 5 hours post iohexol infusion.

MeSH Terms

Conditions

Kidney Diseases; Renal Insufficiency

Interventions

Iohexol

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Sangeeta R. Hingorani, MD, MPH

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 26, 2011
• First Posted: March 6, 2012
• Study Start: September 1, 2008
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 4, 2017

Record last verified: 2016-12

Locations

US (1)