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Monoclonal Gammopathy of Renal SignificanceMGRS-CAPSNCT03629561

Diagnosis of MGRS in Patients With Paraproteinemias: Clinical, Anatomopathological and Pathophysiological Study

An observational study of Monoclonal Gammopathy of Renal Significance, run by Academia Nacional de Medicina at 1 site in Argentina.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is the first prospective study which evaluate patients with small B-cell clones to diagnose monoclonal gammopathy of renal significance (MGRS) and characterize it clinically, anatomopathologically and pathophysiologically taking int account a geriatric approach. Read more about this study

Who is it for?
Ages 18 to 89 years
How many people
15 participants
Where
1 siteArgentina
Study dates
23 Feb 2019to Feb 2021
How long will I take part?
2 Years
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 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Hematological or nephrological patients

Who may be able to join

  • Paraproteinemias

Who cannot join

  • Multiple Myeloma
  • Waldenstrom Macroglobulinemia
  • Chronic Lymphocytic Leukemia
  • Malignant Lymphoma
  • Monoclonal gammopathy of unknown significance (MGUS) secondary to Infections
  • MGUS secondary to Autoimmune Diseases
Show all 16Show fewer
  • Uncompleted hematological evaluation
  • Renal tumor except for cysts Bosniak type I/II
  • Other malignant neoplasia
  • Unresolved obstructive uropathy
  • Patients with only one kidney except for renal transplant
  • Co-morbidities which would limit the ability to receive aggressive therapeutic intervention
  • Fragile old people
  • Pregnancy
  • Prison
  • Impatient in psychiatric institutions.

Trial locations and contacts

1 site in 1 country.

Mariana Ciocchini, Nephrologist contact

+54 9 11 6172 2738

marianaciocchini@pm.me

Argentina1 site, 1 recruiting

  • Academia Nacional de Medicina

    Buenos Aires, 1425ASU

    Mariana Ciocchini, Nephrologist, +54 9 11 6172 2738, marianaciocchini@pm.me

    Recruiting

Other trials in Argentina

About this study

Official title: Diagnosis of Monoclonal Gammopathy of Renal Significance in Patients With Paraproteinemias

This is the first prospective study which evaluate patients with small B-cell clones to diagnose monoclonal gammopathy of renal significance (MGRS) and characterize it clinically, anatomopathologically and pathophysiologically taking int account a geriatric approach.

Keywords
"Paraproteinemias"[Mesh], "Kidney Diseases"[Mesh]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Renal histopathology compatible with MGRS

    Measured: through study completion, an average of 1 year

Secondary outcomes (1)

  1. Renal physiopathological changes

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2018
  2. Study start23 Feb 2019
  3. Primary completionNov 2020 (estimated)
  4. Study completionFeb 2021 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
15 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03629561
Sponsor's protocol ID
T.I. N° 12702/18/H
Acronym
MGRS-CAPS
Status last verified
Jul 2018
First submitted
5 Aug 2018
Last updated
26 Feb 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Ciocchini M, Arbelbide J, Musso CG. Monoclonal gammopathy of renal significance (MGRS): the characteristics and significance of a new meta-entity. Int Urol Nephrol. 2017 Dec;49(12):2171-2175. doi: 10.1007/s11255-017-1594-y. Epub 2017 Apr 19.

    PubMed 28425076

  • Ciocchini M, Musso CG. What is the place of POEMS syndrome in the current classification of monoclonal gammopathies of renal significance? Int Urol Nephrol. 2018 Feb;50(2):383-384. doi: 10.1007/s11255-017-1739-z. Epub 2017 Nov 13. No abstract available.

    PubMed 29134615

  • Ciocchini M, Musso CG. Which should be the correct treatment for monoclonal gammopathy of renal significance with complement alternative pathway dysregulation (C3 glomerulopathy and atypical hemolytic uremic syndrome): clone-directed or anticomplement therapy? Int Urol Nephrol. 2018 Jul;50(7):1365-1366. doi: 10.1007/s11255-018-1896-8. Epub 2018 May 28. No abstract available.

    PubMed 29808447

  • Rosner MH, Edeani A, Yanagita M, Glezerman IG, Leung N; American Society of Nephrology Onco-Nephrology Forum. Paraprotein-Related Kidney Disease: Diagnosing and Treating Monoclonal Gammopathy of Renal Significance. Clin J Am Soc Nephrol. 2016 Dec 7;11(12):2280-2287. doi: 10.2215/CJN.02920316. Epub 2016 Aug 15.

    PubMed 27526705

  • Chauvet S, Fremeaux-Bacchi V, Petitprez F, Karras A, Daniel L, Burtey S, Choukroun G, Delmas Y, Guerrot D, Francois A, Le Quintrec M, Javaugue V, Ribes D, Vrigneaud L, Arnulf B, Goujon JM, Ronco P, Touchard G, Bridoux F. Treatment of B-cell disorder improves renal outcome of patients with monoclonal gammopathy-associated C3 glomerulopathy. Blood. 2017 Mar 16;129(11):1437-1447. doi: 10.1182/blood-2016-08-737163. Epub 2017 Jan 9.

    PubMed 28069603

  • Leung N, Nasr SH. A Patient with Abnormal Kidney Function and a Monoclonal Light Chain in the Urine. Clin J Am Soc Nephrol. 2016 Jun 6;11(6):1073-1082. doi: 10.2215/CJN.10641015. Epub 2016 Mar 18.

    PubMed 26992418

  • Motwani SS, Herlitz L, Monga D, Jhaveri KD, Lam AQ; American Society of Nephrology Onco-Nephrology Forum. Paraprotein-Related Kidney Disease: Glomerular Diseases Associated with Paraproteinemias. Clin J Am Soc Nephrol. 2016 Dec 7;11(12):2260-2272. doi: 10.2215/CJN.02980316. Epub 2016 Aug 15.

    PubMed 27526706

  • Fish R, Pinney J, Jain P, Addison C, Jones C, Jayawardene S, Booth J, Howie AJ, Ghonemy T, Rajabali S, Roberts D, White L, Khan S, Morgan M, Cockwell P, Hutchison CA. The incidence of major hemorrhagic complications after renal biopsies in patients with monoclonal gammopathies. Clin J Am Soc Nephrol. 2010 Nov;5(11):1977-80. doi: 10.2215/CJN.00650110. Epub 2010 Jul 22.

    PubMed 20651154

  • Sethi S, D'Agati VD, Nast CC, Fogo AB, De Vriese AS, Markowitz GS, Glassock RJ, Fervenza FC, Seshan SV, Rule A, Racusen LC, Radhakrishnan J, Winearls CG, Appel GB, Bajema IM, Chang A, Colvin RB, Cook HT, Hariharan S, Herrera Hernandez LP, Kambham N, Mengel M, Nath KA, Rennke HG, Ronco P, Rovin BH, Haas M. A proposal for standardized grading of chronic changes in native kidney biopsy specimens. Kidney Int. 2017 Apr;91(4):787-789. doi: 10.1016/j.kint.2017.01.002.

    PubMed 28314581

  • Moutzouris DA, Herlitz L, Appel GB, Markowitz GS, Freudenthal B, Radhakrishnan J, D'Agati VD. Renal biopsy in the very elderly. Clin J Am Soc Nephrol. 2009 Jun;4(6):1073-82. doi: 10.2215/CJN.00990209. Epub 2009 May 14.

    PubMed 19443626

  • Trimarchi H, Barratt J, Cattran DC, Cook HT, Coppo R, Haas M, Liu ZH, Roberts IS, Yuzawa Y, Zhang H, Feehally J; IgAN Classification Working Group of the International IgA Nephropathy Network and the Renal Pathology Society; Conference Participants. Oxford Classification of IgA nephropathy 2016: an update from the IgA Nephropathy Classification Working Group. Kidney Int. 2017 May;91(5):1014-1021. doi: 10.1016/j.kint.2017.02.003. Epub 2017 Mar 22.

    PubMed 28341274

  • Javaugue V, Bouteau I, Sirac C, Quellard N, Diolez J, Colombo A, Desport E, Ecotiere L, Goujon JM, Fermand JP, Touchard G, Jaccard A, Bridoux F. [Classification and therapeutic management of monoclonal gammopathies of renal significance]. Rev Med Interne. 2018 Mar;39(3):161-170. doi: 10.1016/j.revmed.2017.03.012. Epub 2017 Apr 27. French.

    PubMed 28457684

  • Borza DB, Chedid MF, Colon S, Lager DJ, Leung N, Fervenza FC. Recurrent Goodpasture's disease secondary to a monoclonal IgA1-kappa antibody autoreactive with the alpha1/alpha2 chains of type IV collagen. Am J Kidney Dis. 2005 Feb;45(2):397-406. doi: 10.1053/j.ajkd.2004.09.029.

    PubMed 15685519

  • Vignon M, Cohen C, Faguer S, Noel LH, Guilbeau C, Rabant M, Higgins S, Hummel A, Hertig A, Francois H, Lequintrec M, Vilaine E, Knebelmann B, Pourrat J, Chauveau D, Goujon JM, Javaugue V, Touchard G, El Karoui K, Bridoux F. The clinicopathologic characteristics of kidney diseases related to monotypic IgA deposits. Kidney Int. 2017 Mar;91(3):720-728. doi: 10.1016/j.kint.2016.10.026. Epub 2017 Jan 6.

    PubMed 28069266

  • Stokes MB, Valeri AM, Herlitz L, Khan AM, Siegel DS, Markowitz GS, D'Agati VD. Light Chain Proximal Tubulopathy: Clinical and Pathologic Characteristics in the Modern Treatment Era. J Am Soc Nephrol. 2016 May;27(5):1555-65. doi: 10.1681/ASN.2015020185. Epub 2015 Sep 15.

    PubMed 26374607

Questions about this trial

What is this clinical trial studying?

An observational study of Monoclonal Gammopathy of Renal Significance, run by Academia Nacional de Medicina at 1 site in Argentina.

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 1 inclusion and 16 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 26 Feb 2019. 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 Argentina. 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?

Contact Mariana Ciocchini, Nephrologist (+54 9 11 6172 2738, marianaciocchini@pm.me), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Renal histopathology compatible with MGRS (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03629561, which also lists 29 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 26 Feb 2019.

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