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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease
Observational

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

Study Design

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Study Type :	Observational
Estimated Enrollment :	20 participants
Observational Model:	Case Control
Time Perspective:	Prospective
Official Title:	Progression of Renal Amyloidosis of FMF and Relation to Serum SAA Level
Study Start Date :	September 2010
Estimated Primary Completion Date :	September 2016
Estimated Study Completion Date :	September 2017

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
SAA monitored group; FMF-Amyloidosis patients receiving colchicine with a purpose to normalize SAA levels
Historical control group; FMF-Amyloidosis patients receiving colchicine at a dose determined to stop FMF attacks. obtained from the Fibrillex study

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

20 FMF patients with AA amyloidosis demonstrated by positive biopsy of any target organs

Criteria

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Sheba Medical Center

Investigators

Principal Investigator:	Avi Livneh, MD	Sheba Medical Center

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Responsible Party:	Sheba medical Center, Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT01168570 History of Changes
Other Study ID Numbers:	SHEBA-10-7713-AL-CTIL
First Posted:	July 23, 2010
Last Update Posted:	August 17, 2010
Last Verified:	August 2010

Keywords provided by Sheba Medical Center:

familial Mediterranean fever; amyloidosis AA; serum amyloid A; renal failure; nephrotic syndrome

Additional relevant MeSH terms:

Amyloidosis; Proteostasis Deficiencies; Metabolic Diseases