Diagnosis of MGRS in Patients With Paraproteinemias: Clinical, Anatomopathological and Pathophysiological Study
NCT ID: NCT03629561
Last Updated: 2019-02-26
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
15 participants
Study Classification
OBSERVATIONAL
Study Start Date
2019-02-23
Study Completion Date
2021-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Monoclonal Gammopathy of Renal Significance
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Paraproteinemias
Exclusion Criteria
* Multiple Myeloma
* Waldenstrom Macroglobulinemia
* Chronic Lymphocytic Leukemia
* Malignant Lymphoma
* Monoclonal gammopathy of unknown significance (MGUS) secondary to Infections
* MGUS secondary to Autoimmune Diseases
* 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.
* Waldenstrom Macroglobulinemia
* Chronic Lymphocytic Leukemia
* Malignant Lymphoma
* Monoclonal gammopathy of unknown significance (MGUS) secondary to Infections
* MGUS secondary to Autoimmune Diseases
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
89 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Academia Nacional de Medicina
OTHER
Sponsor Role
lead
Responsible Party
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MARIANA CIOCCHINI
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Academia Nacional de Medicina
Buenos Aires, , Argentina
Site Status
RECRUITING
Countries
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Argentina
Central Contacts
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Facility Contacts
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References
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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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
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BACKGROUND
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.
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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.
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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.
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BACKGROUND
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.
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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.
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BACKGROUND
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.
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BACKGROUND
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.
Reference Type
BACKGROUND
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.
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BACKGROUND
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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.
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BACKGROUND
Eirin A, Irazabal MV, Gertz MA, Dispenzieri A, Lacy MQ, Kumar S, Sethi S, Nasr SH, Cornell LD, Fidler ME, Fervenza FC, Leung N. Clinical features of patients with immunoglobulin light chain amyloidosis (AL) with vascular-limited deposition in the kidney. Nephrol Dial Transplant. 2012 Mar;27(3):1097-101. doi: 10.1093/ndt/gfr381. Epub 2011 Nov 7.
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BACKGROUND
Sicard A, Karras A, Goujon JM, Sirac C, Bender S, Labatut D, Callard P, Sarkozy C, Essig M, Vanhille P, Provot F, Nony A, Nochy D, Ronco P, Bridoux F, Touchard G. Light chain deposition disease without glomerular proteinuria: a diagnostic challenge for the nephrologist. Nephrol Dial Transplant. 2014 Oct;29(10):1894-902. doi: 10.1093/ndt/gfu045. Epub 2014 Mar 11.
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Larsen CP, Ambuzs JM, Bonsib SM, Boils CL, Cossey LN, Messias NC, Silva FG, Wang YH, Gokden N, Walker PD. Membranous-like glomerulopathy with masked IgG kappa deposits. Kidney Int. 2014 Jul;86(1):154-61. doi: 10.1038/ki.2013.548. Epub 2014 Jan 15.
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Ramirez-Alvarado M, Barnidge DR, Murray DL, Dispenzieri A, Marin-Argany M, Dick CJ, Cooper SA, Nasr SH, Ward CJ, Dasari S, Jimenez-Zepeda VH, Leung N. Assessment of renal response with urinary exosomes in patients with AL amyloidosis: A proof of concept. Am J Hematol. 2017 Jun;92(6):536-541. doi: 10.1002/ajh.24717. Epub 2017 May 4.
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Helal I, Fick-Brosnahan GM, Reed-Gitomer B, Schrier RW. Glomerular hyperfiltration: definitions, mechanisms and clinical implications. Nat Rev Nephrol. 2012 Feb 21;8(5):293-300. doi: 10.1038/nrneph.2012.19.
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Saeki T, Kawano M. IgG4-related kidney disease. Kidney Int. 2014 Feb;85(2):251-7. doi: 10.1038/ki.2013.393. Epub 2013 Oct 9.
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Musso CG, Reynaldi J, Martinez B, Pierangelo A, Vilas M, Algranati L. Renal reserve in the oldest old. Int Urol Nephrol. 2011 Mar;43(1):253-6. doi: 10.1007/s11255-010-9769-9. Epub 2010 Jul 1.
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Jhaveri KD, Shah HH, Patel C, Kadiyala A, Stokes MB, Radhakrishnan J. Glomerular diseases associated with cancer, chemotherapy, and hematopoietic stem cell transplantation. Adv Chronic Kidney Dis. 2014 Jan;21(1):48-55. doi: 10.1053/j.ackd.2013.08.003.
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Other Identifiers
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T.I. N° 12702/18/H
Identifier Type: -
Identifier Source: org_study_id
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