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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2010 by Sheba Medical Center
Information provided by:
Sheba Medical Center Identifier:
First received: July 22, 2010
Last updated: August 16, 2010
Last verified: August 2010
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.


Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Progression of Renal Amyloidosis of FMF and Relation to Serum SAA Level

Resource links provided by NLM:

Further study details as provided by Sheba Medical Center:

Estimated Enrollment: 20
Study Start Date: September 2010
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
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

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01168570

Sheba Medical Center Not yet recruiting
Tel Hashomer, Israel, 52621
Principal Investigator: Avi Livneh, MD         
Sponsors and Collaborators
Sheba Medical Center
Principal Investigator: Avi Livneh, MD Sheba Medical Center
  More Information

Responsible Party: Sheba medical Center, Sheba Medical Center Identifier: NCT01168570     History of Changes
Other Study ID Numbers: SHEBA-10-7713-AL-CTIL 
Study First Received: July 22, 2010
Last Updated: August 16, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
familial Mediterranean fever
amyloidosis AA
serum amyloid A
renal failure
nephrotic syndrome

Additional relevant MeSH terms:
Proteostasis Deficiencies
Metabolic Diseases processed this record on October 28, 2016