Your session is about to expire
← Back to Search
Monoclonal Antibodies
Daratumumab for Glomerulonephritis
Phase 2
Recruiting
Led By Fernando Fervenza, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Creatinine clearance ≥ 20 mL/min/SA
For male subjects of reproductive potential who are sexually active with females of reproductive potential, use of a latex or synthetic condom during the study and for 3 months after discontinuing study treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial will test if daratumumab is safe and effective at treating a type of kidney disease called PGNMID.
Who is the study for?
This trial is for people with a kidney condition called PGNMID, who have significant protein in their urine and adequate kidney function. Participants must be able to consent and follow birth control guidelines. Exclusions include pregnancy, certain infections like HIV or hepatitis B/C, recent use of specific cancer drugs without response, severe lung or heart conditions, prior daratumumab treatment, and other health issues that could interfere.Check my eligibility
What is being tested?
Researchers are testing the drug Daratumumab's ability to cause complete or partial remission in patients with proliferative glomerulonephritis with monoclonal immunoglobulin deposits (PGNMID), focusing on its safety and effectiveness.See study design
What are the potential side effects?
While not specified here, Daratumumab can typically cause side effects such as infusion reactions (like fever or chills), fatigue, nausea, back pain, coughing and shortness of breath. It may also affect blood cell counts leading to higher infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidneys are working well enough (creatinine clearance rate is good).
Select...
I will use a condom during the study and for 3 months after it ends.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in proteinuria
Secondary outcome measures
Complete remission status
Hematuria at 12 months
Hematuria at 6 months
+8 moreSide effects data
From 2024 Phase 3 trial • 498 Patients • NCT0213613460%
Thrombocytopenia
50%
Peripheral sensory neuropathy
47%
Peripheral Sensory Neuropathy
36%
Upper respiratory tract infection
36%
Diarrhoea
29%
Cough
28%
Anaemia
23%
Fatigue
23%
Upper Respiratory Tract Infection
23%
Constipation
21%
Back pain
20%
Arthralgia
20%
Oedema peripheral
19%
Neutropenia
19%
Dyspnoea
18%
Insomnia
17%
Pyrexia
16%
Oedema Peripheral
15%
Nausea
14%
Lymphopenia
14%
Pain in extremity
14%
Nasopharyngitis
14%
Bronchitis
14%
Neuralgia
13%
Back Pain
13%
Dizziness
12%
Decreased appetite
12%
Vomiting
12%
Headache
12%
Hypertension
11%
Conjunctivitis
11%
Asthenia
11%
Pneumonia
11%
Hypokalaemia
10%
Muscle spasms
10%
Musculoskeletal chest pain
9%
Urinary tract infection
9%
Leukopenia
9%
Bone pain
9%
Decreased Appetite
9%
Hyperglycaemia
9%
Pain in Extremity
9%
Bronchospasm
8%
Weight decreased
8%
Muscle Spasms
8%
Abdominal pain upper
8%
Alanine aminotransferase increased
7%
Hypophosphataemia
7%
Herpes zoster
7%
Influenza
7%
Hypocalcaemia
7%
Alanine Aminotransferase Increased
7%
Rash
6%
Musculoskeletal Chest Pain
6%
Myalgia
6%
Aspartate aminotransferase increased
6%
Nasal congestion
6%
Abdominal pain
5%
Bone Pain
5%
Hypotension
5%
Abdominal Pain Upper
5%
Weight Decreased
5%
Chills
5%
Productive cough
5%
Throat irritation
5%
Herpes Zoster
5%
Oedema
5%
Paraesthesia
5%
Epistaxis
4%
Dyspepsia
2%
Atrial fibrillation
2%
Acute kidney injury
2%
Sepsis
2%
Atrial Fibrillation
1%
Acute myocardial infarction
1%
Pneumonia cytomegaloviral
1%
Pleural effusion
1%
Rib fracture
1%
Lower Respiratory Tract Infection
1%
Pulmonary sepsis
1%
Squamous cell carcinoma of skin
1%
Pulmonary Sepsis
1%
Hypercalcaemia
1%
Pneumonia Cytomegaloviral
1%
Cardiac failure congestive
1%
Acute coronary syndrome
1%
Lower respiratory tract infection
1%
Hip fracture
1%
Angina unstable
1%
Cerebrovascular accident
1%
Ischaemic stroke
1%
Bronchitis chronic
1%
Humerus fracture
1%
Respiratory failure
1%
Gastroenteritis
1%
Pathological fracture
1%
Femur fracture
1%
Febrile neutropenia
1%
Ischaemic Stroke
1%
Respiratory Failure
1%
Pathological Fracture
1%
Febrile Neutropenia
1%
Cardiac Failure Congestive
1%
Bronchopneumonia
1%
Femur Fracture
1%
Humerus Fracture
1%
Acute Kidney Injury
1%
Pleural Effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Daratumumab + Bortezomib and Dexamethasone (DVd)
Bortezomib + Dexamethasone (Vd)
Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy
Trial Design
1Treatment groups
Experimental Treatment
Group I: Daratumumab treatment in PGNMIDExperimental Treatment1 Intervention
Subjects with native kidney biopsy consistent with membranoproliferative glomerulonephritis with monoclonal immunoglobulin deposits will receive daratumumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
2014
Completed Phase 3
~1990
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,216 Previous Clinical Trials
3,767,448 Total Patients Enrolled
3 Trials studying Glomerulonephritis
41 Patients Enrolled for Glomerulonephritis
Fernando Fervenza, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidneys are working well enough (creatinine clearance rate is good).I am unable to give my consent.I have not received any live vaccines in the last 4 weeks.I've been taking a low dose of prednisone or similar for a condition not related to PGNMID.I have taken rituximab and my CD20 count is below 20 cells/microliter now.You have more than 1000 milligrams of protein in your urine over a 24-hour period.You have tested positive for hepatitis B surface antigen (HBsAg).You have hepatitis C, unless the infection has been successfully treated and the virus is no longer detectable in your blood.My multiple myeloma diagnosis includes specific test results and symptoms.I will use a condom during the study and for 3 months after it ends.I have taken immunosuppressive drugs like MMF, cyclosporine, tacrolimus, or azathioprine in the past 3 months.A kidney biopsy done at Mayo Clinic confirms the diagnosis of PGNMID.I haven't had a heart attack or uncontrolled heart problems in the last 6 months.I've been treated with cyclophosphamide or bortezomib without clear results.My lung function is less than half of what it should be due to COPD.I have had severe or uncontrolled asthma in the last 2 years.I haven't been treated with daratumumab or similar drugs, nor participated in other drug trials recently.You have tested positive for HIV.You have very low levels of red blood cells, platelets, white blood cells, or neutrophils, or high levels of certain liver enzymes or bilirubin.I had cancer other than multiple myeloma, was treated over 2 years ago, and currently show no signs of the disease.
Research Study Groups:
This trial has the following groups:- Group 1: Daratumumab treatment in PGNMID
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How could administering Daratumumab to individuals with PGNMID potentially be hazardous?
"Our team at Power has evaluated the safety of Daratumumab treatment in PGNMID on a scale from 1 to 3, and have concluded that it merits 2 points due to the lack of efficacy data collected during the Phase 2 trial."
Answered by AI
Is there a call for volunteers in this medical research experiment?
"Clinicaltrials.gov confirms that this trial is not enrolling new participants at the moment, as its initial posting on January 1st 2023 was last updated on December 8th 2022. Nonetheless, there are 21 different studies recruiting patients right now."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger