DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Progression of Renal Amyloidosis of FMF and Relation to Serum SAA Level

Information source: Sheba Medical Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Observational

Phase: N/A

Status: Not yet recruiting

Sponsored by: Sheba Medical Center

Official(s) and/or principal investigator(s):
Avi Livneh, MD, Principal Investigator, Affiliation: Sheba Medical Center


Purpose of this study is to determine whether keeping SAA on normal or near normal level will delay progression of renal failure in patients with amyloidosis secondary to FMF.

Clinical Details

Official title: Progression of Renal Amyloidosis of FMF and Relation to Serum SAA Level

Study design: Observational Model: Case Control, Time Perspective: Prospective

Detailed description: FMF is an inherited inflammatory disorder typically presented in most causes as recurrent episodes of fever and serositis. Phenotype II, another kind of this disorder, has atypical courses, when the inflammation proceeds without any clinical sign. Each FMF attack is accompanied by sharp elevation of inflammatory markers in the serum, and serum amyloid A (SAA) one of them. The level of these inflammatory markers returns to normal with termination of the attack. The SAA is the main component of amyloids fibrils and constantly high level of SAA after the attack (as occurs in undiagnosed or undertreated disease) is the significant risk factor responsible for development of amyloidosis. On the other hand, in patients with phenotype II the amyloidosis occurs despite absolute absence of the attacks. The kidney is one of the first organ suffers from amyloid deposits. The spectrum of kidney damage spread wildly from mild proteinuria to obvious nephrotic syndrome with disturbance in renal function and progression to end stage renal failure. It is well known that deterioration of renal disease in AA amyloidosis links to level of SAA in serum. The permanently high SAA level is a major factor responsible to progression of renal disease. Occasionally, however, decline in the renal function occurred despite normal or near normal levels of SAA. Renal impairment in these cases may be explained by mechanisms existing in other kidney diseases when uncontrolled proteinuria aggravates renal dysfunction. The purpose of the study is to find whether a cohort of patients followed in our clinic and receiving colchicine for FMF- amyloidosis according to the SAA levels, monitored periodically, have better prognosis than an historical cohort receiving colchicine according to the attack status


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- FMF patients with amyloidosis AA

- 18 year and older

Exclusion Criteria:

- patients with AA amyloidosis not related to FMF

- evidence of other primary renal disease or renovascular pathology

- evidence of renal disease secondary to any systemic illness

- presence of inflammatory, autoimmune conditions or chronic infection that could lead

to high SAA level

- pregnancy

- inability to provide legal consent

Locations and Contacts

Sheba Medical Center, Tel Hashomer 52621, Israel; Not yet recruiting
Avi Livneh, MD, Principal Investigator
Additional Information

Related publications:

Lachmann HJ, Goodman HJ, Gilbertson JA, Gallimore JR, Sabin CA, Gillmore JD, Hawkins PN. Natural history and outcome in systemic AA amyloidosis. N Engl J Med. 2007 Jun 7;356(23):2361-71.

Gillmore JD, Lovat LB, Persey MR, Pepys MB, Hawkins PN. Amyloid load and clinical outcome in AA amyloidosis in relation to circulating concentration of serum amyloid A protein. Lancet. 2001 Jul 7;358(9275):24-9.

Yalçinkaya F, Cakar N, Acar B, Tutar E, Güriz H, Elhan AH, Oztürk S, Kansu A, Ince E, Atalay S, Girgin N, Doğru U, Aysev D, Ekim M. The value of the levels of acute phase reactants for the prediction of familial Mediterranean fever associated amyloidosis: a case control study. Rheumatol Int. 2007 Apr;27(6):517-22. Epub 2006 Nov 14.

Starting date: September 2010
Last updated: August 16, 2010

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017