Health TrialsbyHealthPanel

Obinutuzumab in Treatment of Fibrillary Glomerulonephritis

ConditionFibrillary Glomerulonephritis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

The purpose of this research is to learn if Obinutuzumab is effective and safe in treating patients with fibrillary glomerulonephritis (FGN).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years of age

Biopsy proven fibrillary glomerulonephritis

Proteinuria > 1.0 g/24hrs prior to initiation of immunosuppressive therapy

eGFR ≥ 20 ml/min/BSA

Disqualifiers

Secondary FGN (due to monoclonal gammopathy, autoimmune disease or malignancy)

Presence of a secondary pathology on biopsy (e.g. diabetic nephropathy)

Hepatitis B, C or HIV positive

Pregnant or breast-feeding

Trial design

Design model

Single group

Treatments tested in this trial

  • Obinutuzumab

    Drug

    Obinutuzumab 1g IV on day one and 1 g IV on day 15, followed by identical course at month 6.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Obinutuzumab in Treatment of Fibrillary GlomerulonephritisExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in proteinuria from baseline to 12 months post treatment with Obinutuzumab

Measured using 24-hour urine collection reported in mg/24h

Time frame
Baseline, 6 months, 12 months

Secondary outcomes

1

Change in proteinuria from baseline to 6 months post treatment with Obinutuzumab

Measured using 24-hour urine collection reported in mg/24h

Time frame
Baseline, 6 months
2

Rate of complete or partial remission

Complete remission: Proteinuria \< 0.5g/24 hrs. and no more than 20% decline in eGFR Partial remission: 50% reduction in proteinuria and proteinuria \< 3.5 g/24hrs and no more than 20% decline in eGFR

Time frame
6 months, 12 months
3

Improvement in serum albumin

Blood serum collected and reported in g/dL

Time frame
Baseline, 6 months, 12 months
4

Stabilization of kidney function

Stabilization is defined as no more than 20% decline in eGFR at 6 months and 12 months. Blood serum collected and reported in mL/min/BSA.

Time frame
Baseline, 6 months, 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
Apply now