- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01168570
Progression of Renal Amyloidosis of FMF and Relation to Serum SAA Level
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Tel Hashomer, Israel, 52621
- Sheba Medical Center
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Principal Investigator:
- Avi Livneh, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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SAA monitored group
FMF-Amyloidosis patients receiving colchicine with a purpose to normalize SAA levels
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Historical control group
FMF-Amyloidosis patients receiving colchicine at a dose determined to stop FMF attacks.
obtained from the Fibrillex study
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Collaborators and Investigators
Sponsor
Publications and helpful links
General 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. doi: 10.1056/NEJMoa070265.
- 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. doi: 10.1016/S0140-6736(00)05252-1.
- Yalcinkaya 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHEBA-10-7713-AL-CTIL
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