Progression of Renal Amyloidosis of FMF and Relation to Serum SAA Level
1 other identifier
observational
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2010
CompletedFirst Posted
Study publicly available on registry
July 23, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedAugust 17, 2010
August 1, 2010
6 years
July 22, 2010
August 16, 2010
Conditions
Keywords
Study Arms (2)
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
Eligibility Criteria
20 FMF patients with AA amyloidosis demonstrated by positive biopsy of any target organs
You may qualify if:
- FMF patients with amyloidosis AA
- year and older
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sheba Medical Center
Tel Litwinsky, 52621, Israel
Related Publications (3)
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. doi: 10.1056/NEJMoa070265.
PMID: 17554117BACKGROUNDGillmore 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. doi: 10.1016/S0140-6736(00)05252-1.
PMID: 11454373BACKGROUNDYalcinkaya F, Cakar N, Acar B, Tutar E, Guriz H, Elhan AH, Ozturk S, Kansu A, Ince E, Atalay S, Girgin N, Dogru 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. doi: 10.1007/s00296-006-0265-6. Epub 2006 Nov 14.
PMID: 17103173BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Avi Livneh, MD
Sheba Medical Center
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
July 22, 2010
First Posted
July 23, 2010
Study Start
September 1, 2010
Primary Completion
September 1, 2016
Study Completion
September 1, 2017
Last Updated
August 17, 2010
Record last verified: 2010-08