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

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ClinicalTrials.gov Identifier: NCT01168570
Recruitment Status : Unknown
Verified August 2010 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 23, 2010
Last Update Posted : August 17, 2010
Sponsor:
Information provided by:
Sheba Medical Center

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis
U.S. FDA Resources

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




Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01168570


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