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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2010 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01168570
First Posted: July 23, 2010
Last Update Posted: August 17, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sheba Medical Center
  Purpose
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
Observational

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)
Groups/Cohorts
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

  Eligibility

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
  Contacts and Locations
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
  More Information

Publications:
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 Submitted: July 22, 2010
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