Rituximab in Progressive Immunoglobulin A (IgA) Nephropathy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2015-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study was about IgA nephropathy, a form of kidney disease characterized by the presence of blood and protein in the urine. This study was done to determine if the medication rituximab could reduce protein in the patient's urine.

Hypothesis: In patients with progressive IgA nephropathy an intravenous infusion of 1000 mg of rituximab on Day 1 and Day 15 and Days 168 and 182 is superior to conventional therapy in reducing 24 hour proteinuria, and slowing progression of chronic kidney disease.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Rituximab for the Treatment of Early Rheumatoid Arthritis (RA)

NCT00396812

Rheumatoid Arthritis

TERMINATED PHASE1/PHASE2

A Study of the Safety of Rituximab in Combination With Other Anti-Rheumatic Drugs in Subjects With Active Rheumatoid Arthritis

NCT00443651

Rheumatoid Arthritis

COMPLETED PHASE3

Rituximab in IgG4-RD: A Phase 1-2 Trial

NCT01584388

Retroperitoneal Fibrosis Autoimmune Pancreatitis Sialadenitis +1 more

COMPLETED PHASE1/PHASE2

Rituxan With or Without Methotrexate in Psoriatic Arthritis

NCT00509678

Psoriatic Arthritis

COMPLETED PHASE1

Prospective Validation of a Pharmacological Biomarker for Low-Dose Rituximab in Rheumatoid Arthritis

NCT06933134

Rheumatoid Arthritis (RA)

NOT_YET_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Recent clinical success in the use of Rituximab in the treatment of Lupus nephritis and other forms immune complex glomerulonephritis has led to its investigation in the treatment of IgA nephropathy. Because IgA class antibodies have comparatively short half-lives and that deposition of polymeric forms of IgA contributes to glomerular injury, the researchers speculated that the reduction of circulating IgA could reduce proteinuria and injury in patients with IgA nephropathy.

Treatment and Follow-up:

Subjects were randomly assigned to receive rituximab or to continue standard care. Both arms received a Omega-3 Fatty Acid Fish Oil Supplement and angiotensin converting enzyme (ACE) inhibitors and/or Angiotensin II receptor blockers (ARBs). ACE inhibitors and/or ARBs were used to achieve a blood pressure goal of \<130/80 mmHg.

The study was an open-label trial; those assigned to rituximab received a 1 g infusion of rituximab followed by an identical dose 2 weeks later. Premedication with corticosteroids (10 mg dexamethasone intravenously) was also given 30 min prior to the first infusion of each series of rituximab. They received an identical 2 g course of rituximab 6 months later. Subjects were assessed at least every 3 months or as needed for clinical events. This assessment included physical examination, a questionnaire for adverse events, and measurement of routine hematology, serum chemistry, timed urine protein excretion, and for those assigned to rituximab, B-cell subsets. Follow-up was considered complete at 12 months.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

IgA Nephropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Rituximab Plus ACE/ARB

Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement

Group Type EXPERIMENTAL

Intravenous Rituximab

Intervention Type DRUG

Rituximab Therapy \[27 Patients\]

* Rituximab 1 gm IV on Treatment Day 1
* Rituximab 1 gm IV on Treatment Day 15
* Rituximab 1 gm IV on Treatment Day 168
* Rituximab 1 gm IV on Treatment Day 182

ACE/ARB

Intervention Type DRUG

ACE inhibitors and /or ARBs will be used to achieve a blood pressure goal of \<130/80 millimeters of mercury (mmHg). Patients not attaining the target blood pressure with an ACE inhibitor or ARB alone should be treated with the combination of ACE inhibitor (ACEi) + ARB

Omega-3 Fatty Acid Fish Oil Supplement

Intervention Type DIETARY_SUPPLEMENT

Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day

ACE/ARB

ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement

Group Type ACTIVE_COMPARATOR

ACE/ARB

Intervention Type DRUG

ACE inhibitors and /or ARBs will be used to achieve a blood pressure goal of \<130/80 millimeters of mercury (mmHg). Patients not attaining the target blood pressure with an ACE inhibitor or ARB alone should be treated with the combination of ACE inhibitor (ACEi) + ARB

Omega-3 Fatty Acid Fish Oil Supplement

Intervention Type DIETARY_SUPPLEMENT

Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intravenous Rituximab

Rituximab Therapy \[27 Patients\]

* Rituximab 1 gm IV on Treatment Day 1
* Rituximab 1 gm IV on Treatment Day 15
* Rituximab 1 gm IV on Treatment Day 168
* Rituximab 1 gm IV on Treatment Day 182

Intervention Type DRUG

ACE/ARB

ACE inhibitors and /or ARBs will be used to achieve a blood pressure goal of \<130/80 millimeters of mercury (mmHg). Patients not attaining the target blood pressure with an ACE inhibitor or ARB alone should be treated with the combination of ACE inhibitor (ACEi) + ARB

Intervention Type DRUG

Omega-3 Fatty Acid Fish Oil Supplement

Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Rituxan Angiotensin II blockade

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Any patient between the age of 18 and 70 years of age and able to give informed consent
* GFR by Cockcroft-Gault or MDRD equations \<90 mls/min and \>30 mls/min
* Greater than or equal to 1000 mg of proteinuria/24 hours while on stable ACEi, ARB or renin inhibitor therapy for 2 months. Patients receiving combination ACE or ARB or ACEi and a renin inhibitor for 2 months will only require 500mg/24 hours
* Blood pressure \<130/80 mmHg. The presence of hypertension is not required for study entry, but any patient requiring long term hypertensive medications must have blood pressure controlled \<130-80 mmHg, to be considered eligible for the study
* Female patients with IgA will be considered eligible for study entry if they have a negative urine or serum pregnancy test at the time of screening are agreeable to 2 years of contraception
* Biopsy proven IgA nephropathy and clinical features consistent with Henoch Schonlein Purpura will be considered eligible for the study
* Able to swallow the oral medications

Exclusion Criteria

* Clinical and histologic evidence of IgA predominant Lupus nephritis
* Clinical and histologic evidence of idiopathic IgA forms of membranoproliferative glomerulonephritis
* Clinical evidence of cirrhosis, chronic active liver disease or known infection with hepatitis B, C or HIV
* Estimated GFR \<30 ml/min/1.73m² at the time of screening
* Greater than 50% glomerular senescence or cortical scarring on renal biopsy
* Active systemic infection or history of serious infection within one month of entry
* History of Crohn's disease or Celiac Sprue
* Positive pregnancy test or breast feeding at time of study entry or unwilling to comply with contraceptive measures
* Current or recent (within 30 days) exposure to any investigational drug
* Serum Cr \>3.5 mg/dl or Modification of Diet in Renal Disease (MDRD) calculated GFR \<30 mls/min
* Patients receiving \>6 months therapy with oral prednisone or glucocorticoid equivalent
* Live vaccine within 28 days of study enrollment.

* Patients with anaphylaxis and/or known allergic reactions to Rituximab
* Hemoglobin: \<8.5 gm/dL
* Platelets: \<100,000/mm
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.5 x Upper Limit of Normal unless related to primary disease.
* Previous Treatment with Rituximab(MabThera®/Rituxan®)
* Previous treatment with Natalizumab(Tysabri®)
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
* History of recurrent significant infection or recurrent bacterial infections
* Known active bacterial, viral fungal mycobacterial or atypical mycobacterial infections, but excluding fungal infections of nail beds
* Any major episode of infection requiring hospitalization or treatment with i.v. antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening
* Ongoing use of high dose steroids(\>10 mg/day)or unstable steroid dose in the past 4 weeks
* Lack of peripheral venous access
* History of drug, alcohol, or chemical abuse within 6 months prior to screening
* Pregnancy (a negative serum or urine pregnancy test will be performed for all women of childbearing potential no later than 7 days prior to treatment) or lactation
* Concomitant or previous malignancies, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
* History of psychiatric disorder that would interfere with normal participation in this protocol
* Significant cardiac or pulmonary disease (including obstructive pulmonary disease)
* Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complication
* Inability to comply with study and follow-up procedures

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No