ObservationalNCT01168570
Progression of Renal Amyloidosis of FMF and Relation to Serum SAA Level
An observational study of Observational, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Observational
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2010to Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 20 FMF patients with AA amyloidosis demonstrated by positive biopsy of any target organs
Who may be able to join
- FMF patients with amyloidosis AA
- 18 year and older
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Observational
- Keywords
- familial Mediterranean fever, amyloidosis AA, serum amyloid A, renal failure, nephrotic syndrome
- Medical subject headings
- Familial Mediterranean Fever, AA amyloidosis, Renal Insufficiency, Nephrotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2016 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObservationalStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Avi Livneh, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01168570
- Sponsor's protocol ID
- SHEBA-10-7713-AL-CTIL
- Status last verified
- Aug 2010
- First submitted
- 22 Jul 2010
- Last updated
- 17 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 17554117Gillmore 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.
PubMed 11454373Yalcinkaya 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.
PubMed 17103173
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progression of Renal Amyloidosis of FMF and Relation to Serum SAA Level
- ClinicalTrials.gov ID
- NCT01168570
- Acronym / sponsor ID
- SHEBA-10-7713-AL-CTIL
- Conditions
- Observational
- Keywords
- familial Mediterranean fever, amyloidosis AA, serum amyloid A, renal failure, nephrotic syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Sep 2010
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 23 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 20 FMF patients with AA amyloidosis demonstrated by positive biopsy of any target organs
Key inclusion criteria (2 listed)
- FMF patients with amyloidosis AA
- 18 year and older
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2010.
- Background: PubMed 17554117Lachmann 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.
- Background: PubMed 11454373Gillmore 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.
- Background: PubMed 17103173Yalcinkaya 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Avi Livneh, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Observational, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01168570, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2010.