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Enzyme
Imlifidase for Goodpasture Syndrome (GOOD-IDES-02 Trial)
Phase 3
Recruiting
Research Sponsored by Hansa Biopharma AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
eGFR(MDRD) <20 mL/min/1.73 m^2
Patients aged ≥18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at screening and at 3 and 6 months
Awards & highlights
GOOD-IDES-02 Trial Summary
This trial will compare a new treatment to the standard one for kidney issues, with patients monitored for two years.
Who is the study for?
This trial is for adults over 18 with severe anti-GBM disease, indicated by specific kidney function tests and presence of certain antibodies. They must have blood in their urine and not have been treated with standard care or immune globulins recently. Pregnant or breastfeeding individuals, those with conditions posing extra risks, or anuria (no urine output) in the last day are excluded.Check my eligibility
What is being tested?
The study compares a new treatment approach using Imlifidase alongside standard therapies like plasma exchange, cyclophosphamide, and glucocorticoids against the standard treatments alone. It's designed to see if adding Imlifidase improves kidney function in patients with anti-GBM disease over two years.See study design
What are the potential side effects?
Imlifidase may cause allergic reactions, infections due to weakened immunity from plasma exchange and immunosuppressive drugs like cyclophosphamide and glucocorticoids can lead to increased infection risk, bleeding issues, bone marrow suppression, nausea/vomiting.
GOOD-IDES-02 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is severely reduced.
Select...
I am 18 years old or older.
GOOD-IDES-02 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at randomisation and at 3 and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at randomisation and at 3 and 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Renal function as evaluated by estimated glomerular filtration rate (eGFR) at 6 months
Secondary outcome measures
Anti-imlifidase antibody levels from start of imlifidase treatment to 6 months
Change in health related quality of life (HRQoL) from screening to 6 months
Change in health status from screening to 6 months
+19 moreGOOD-IDES-02 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Imlifidase and Standard-of-Care (SoC)Experimental Treatment4 Interventions
Imlifidase is administered IV as one dose of 0.50 mg/kg over 30 minutes.
SoC consists of a standardized combination of PLEX, CYC, and glucocorticoids.
Group II: Standard-of-Care (SoC)Active Control3 Interventions
SoC consists of a standardized combination of PLEX, CYC, and glucocorticoids.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glucocorticoids
2011
Completed Phase 4
~1250
Imlifidase
2017
Completed Phase 2
~80
Plasma exchange (PLEX)
2012
N/A
~10
Find a Location
Who is running the clinical trial?
Hansa Biopharma ABLead Sponsor
18 Previous Clinical Trials
739 Total Patients Enrolled
Clinical OperationsStudy DirectorHansa Biopharma AB
19 Previous Clinical Trials
2,261 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not urinated in the last 24 hours.I have antibodies that require a special blood filtering treatment.I was diagnosed with anti-GBM disease over two weeks ago.My kidney function is severely reduced.I haven't received standard cancer treatment in the last 10 days.I have not received IVIg treatment in the last 4 weeks.Blood in your urine.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Imlifidase and Standard-of-Care (SoC)
- Group 2: Standard-of-Care (SoC)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
To what extent could Imlifidase and Standard-of-Care (SoC) pose a hazard to individuals?
"Our experts assigned Imlifidase and Standard-of-Care (SoC) a rating of 3 due to the Phase 3 trial, which has provided evidence for both effectiveness and security."
Answered by AI
How many participants are currently participating in the research project?
"Affirmative. According to the clinicaltrials.gov website, this trial is actively seeking participants since its initial posting on December 22nd 2022 and most recent update of December 23rd 2022. The study necessitates enrollment of 50 patients from a single site."
Answered by AI
Are there any openings presently available to enroll in this trial?
"According to the clinicaltrials.gov, this medical trial is currently open for participant enrollment and was first posted on December 22nd 2022 with a recent update occurring on December 23rd 2022."
Answered by AI
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