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Prediction of Outcome of Lupus Nephritis

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ClinicalTrials.gov Identifier: NCT02403115
Recruitment Status : Recruiting
First Posted : March 31, 2015
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):
Gian Marco Ghiggeri MD, PhD, Istituto Giannina Gaslini

Brief Summary:

The purpose of this study is to clarify the mechanisms involved in the formation and glomerular deposition of immune complexes in lupus nephritis.

The determination of an antibody pattern specific for systemic lupus erythematosus and lupus nephritis may also have a role in predicting disease progression in patients with systemic lupus erythematosus without renal impairment. As for the patients enrolled in the study, the determination of their antibody patterns may contribute to a more targeted and personalized treatment, allowing a prediction of disease progression and the introduction of early targeted treatments, in order to block the onset and/or progression of renal damage.


Condition or disease Intervention/treatment
Systemic Lupus Erythematosus Other: Serum collection

Detailed Description:

Prospective multicenter study on the validity of levels of circulating antibodies to glomerular neo-autoantigens (alpha-enolase and annexin AI) and implantable antigens (anti-DNA, histone, istone3, istone4, C1q) as a surrogate biomarker for the diagnosis of lupus nephritis.

The study will involve the collection of serum from patients with lupus nephritis at onset and during subsequent follow-up at 6, 12, 24 and 36 months for the titration of circulating autoantibodies.

As a control the investigators will use the sera of patients with systemic lupus erythematosus without nephropathy, collected at the same time intervals.

The investigators will also assess the antibody positivity in groups of patients with rheumatologic disease similar to lupus (rheumatoid arthritis) and in patients with autoimmune nephropathy without extrarenal clinical signs.

Regarding patients with systemic lupus erythematosus the investigators will collect sera of both incident and prevalent patients in order to monitor changes in antibody levels in conjunction with the development of renal disease.

Clinical tests (renal function, complete blood count, C reactive protein (CRP), ANA, native DNA (nDNA), urine analysis) will be performed at 6, 12, 24 and 36 months and the surplus of blood samples will be used to create the serum bank of the study.

Samples will be collected in the pediatric nephrology of Giannina Gaslini Children Hospital, Genoa (coordinator centre) and in 5 rheumatological (Genoa, Pisa, Pavia, Padova, Brescia) and 6 nephrological (Milan, Genoa, Parma, Brescia, Bologna and Reggio Emilia) italian adults departments .


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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of the Assay of Circulating Antibodies Against Glomerular Neo-autoantigens as a Surrogate Biomarker of the Development of Lupus Nephritis
Study Start Date : October 2014
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2020


Group/Cohort Intervention/treatment
Lupus Nephritis
Collection of serum at onset and during subsequent follow-up at 6, 12, 24 and 36 months for the dosage of circulating autoantibodies.
Other: Serum collection
Clinical tests (renal function, complete blood count, CRP, ANA, dsDNA, urinalysis) will be performed at fixed time intervals (6, 12, 24 and 36 months) and the surplus of blood sample will form the serum bank used for the study

Incident SLE without nephritis
Collection of serum at onset and during subsequent follow-up at 6, 12, 24 and 36 months for the dosage of circulating autoantibodies, in order to evaluate the presence of nephritic manifestations.
Other: Serum collection
Clinical tests (renal function, complete blood count, CRP, ANA, dsDNA, urinalysis) will be performed at fixed time intervals (6, 12, 24 and 36 months) and the surplus of blood sample will form the serum bank used for the study

Prevalent SLE without nephritis
Collection of serum at onset and during subsequent follow-up at 6, 12, 24 and 36 months for the dosage of circulating autoantibodies in order to evaluate the presence of nephritic manifestations.
Other: Serum collection
Clinical tests (renal function, complete blood count, CRP, ANA, dsDNA, urinalysis) will be performed at fixed time intervals (6, 12, 24 and 36 months) and the surplus of blood sample will form the serum bank used for the study

Rheumatoid arthritis
Collection of serum at onset and during subsequent follow-up at 6, 12, 24 and 36 months for the dosage of circulating autoantibodies in order to evaluate the presence of nephritic manifestations.
Other: Serum collection
Clinical tests (renal function, complete blood count, CRP, ANA, dsDNA, urinalysis) will be performed at fixed time intervals (6, 12, 24 and 36 months) and the surplus of blood sample will form the serum bank used for the study

Membranous glomerulonephritis
Collection of serum at onset and during subsequent follow-up at 6, 12, 24 and 36 months for the dosage of circulating autoantibodies in order to exclude secondary forms of the disease.
Other: Serum collection
Clinical tests (renal function, complete blood count, CRP, ANA, dsDNA, urinalysis) will be performed at fixed time intervals (6, 12, 24 and 36 months) and the surplus of blood sample will form the serum bank used for the study




Primary Outcome Measures :
  1. Change from baseline in Proteinuria at 12, 24 and 36 months [ Time Frame: 12, 24, 36 months ]
    proteinuria measured on a 24-hour urine collection.


Secondary Outcome Measures :
  1. Renal function [ Time Frame: 36 months ]
    estimated glomerular filtration rate (eGFR) measured according to Revised Bedside Schwartz Formula (4-17 years old patients) or CKD-EPI Creatinine 2009 Equation (18-64 years old patients)


Biospecimen Retention:   Samples Without DNA
Serum


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Ages Eligible for Study:   4 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
  • 250 patients with newly diagnosed lupus nephritis (stage I-VI according to WHO classification). First serum will be collected at the time of renal biopsy (study group).
  • 250 patients with incident or prevalent systemic lupus erythematosus (according to ARA criteria) and no signs of nephropathy (control group).
  • 50 patients with rheumatoid arthritis (according to ARA criteria), without documented nephropathy (control group)
  • 250 patients with histological diagnosis of membranous nephropathy (control group).
Criteria

Inclusion Criteria:

  • Age between 4 and 65 years
  • Diagnosis of lupus nephritis-systemic lupus erythematosus (systemic lupus erythematosus, rheumatoid arthritis and membranous nephropathy for controls)
  • Informed consent

Exclusion Criteria:

  • Severe infections in place
  • Malignancies of any current or history
  • Chronic hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) positive
  • Breast-feeding or pregnant
  • Known hypersensitivity to drugs

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): NCT02403115


Contacts
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Contact: Gian Marco Ghiggeri, MD 0039 010 56362419 gmarcoghiggeri@ospedale-gaslini.ge.it

Locations
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Italy
IRCCS Giannina Gaslini Children Hospital Recruiting
Genoa, Italy/GE, Italy, 16147
Contact: Gian Marco Ghiggeri, MD    0039 010 5636 2419    gmarcoghiggeri@ospedale-gaslini.ge.it   
Principal Investigator: Gian Marco Ghiggeri, MD         
Sub-Investigator: Alice Bonanni, MD         
Sponsors and Collaborators
Istituto Giannina Gaslini
Investigators
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Study Director: Gian Marco Ghiggeri, MD IRCCS Giannina Gaslini, Genoa

Publications of Results:
Other Publications:
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Responsible Party: Gian Marco Ghiggeri MD, PhD, MD, Istituto Giannina Gaslini
ClinicalTrials.gov Identifier: NCT02403115     History of Changes
Other Study ID Numbers: SLE1
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Nephritis
Lupus Nephritis
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Kidney Diseases
Urologic Diseases
Glomerulonephritis