Trial to Assess Safety and Efficacy of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN)

  • STATUS
    Recruiting
  • End date
    May 15, 2022
  • participants needed
    30
  • sponsor
    MorphoSys AG
Updated on 15 October 2020
Investigator
Winrich H Rauschning, MD PhD MBA
Primary Contact
CHU Saint Etienne - H pital Nord (0.0 mi away) Contact
+27 other location
remission
tacrolimus
cyclophosphamide
cyclosporine
immunosuppressive agents
ace inhibitor
glomerular filtration rate
angiotensin
ACTH
corticotropin
immunosuppression
alkylating agents
mycophenolate
enzyme inhibitor
angiotensin converting enzyme
mor202

Summary

This is an open-label, multicentre study to characterize the safety and efficacy of the human anti-CD38 antibody MOR202 in adult subjects with in Anti-PLA2R Antibody Positive Membranous Nephropathy (newly diagnosed/relapsed/refractory)

Description

After treatment subjects will be observed for up to 1 year.

Details
Treatment MOR202
Clinical Study IdentifierNCT04145440
SponsorMorphoSys AG
Last Modified on15 October 2020

Adding a note
adding personal notes guide

Select a piece of text and start making personal notes.

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 80 yrs?
Gender: Male or Female
Do you have any of these conditions: Idiopathic Membranous Nephropathy or Membranous glomerulonephritis or antiPLA2R Positive?
Urine protein to creatinine ratio of 3.0 g/g (as measured from a 24 hour urine collection)
Active anti-PLA2R antibody positive MN in need for immunosuppressive therapy (IST) according to investigator judgement and diagnosed on the basis of a biopsy, archival biopsy acquired within 5 years prior to screening is acceptable
Estimated glomerular filtration rate 50 ml/min/1.73m or >30 and <50 ml/min/1.73m, and interstitial fibrosis and tubular atrophy score of less than 25% on a renal biopsy obtained within the last 6 months prior to start of screening
on supportive treatment with an Angiotensin Converting Enzyme Inhibitor or an Angiotensin II Receptor Blocker for at least 4 weeks prior to Screening, having reached a stable dose
Systolic BP 150 mmHg and diastolic BP 100 mmHg
Vaccinated against Pneumococcus within the last 3 years prior to date of signing informed consent (subjects may be vaccinated during screening to meet this criterion; interval to first dose of MOR202 must be at least 14 days)
Cohort 1a (newly diagnosed patients): Serum anti-PLA2R antibodies 150.0 Response Units(RU)/mL determined at screening by Euroimmun ELISA
Cohort 1b, relapse subjects: Must have had complete immunological and/or clinical remission according to judgement of the investigator and serum anti-PLA2R antibodies 50.0 RU/mL determined at screening by Euroimmun ELISA
Cohort 2: Failure of previous therapy, i.e. subject never achieved a complete immunological and/or clinical remission according to judgement of the investigator. during or after completion of a recognized IST containing cyclosporine A, tacrolimus, mycophenolate-mofetil, ACTH or alkylating agents (e.g. cyclophosphamide), or rituximab. Serum anti-PLA2R antibodies 20.0 RU/mL determined at screening by the Euroimmun ELISA

Exclusion Criteria

Hemoglobin <90 g/L
Thrombocytopenia: Platelets <100.0x109/L
Neutropenia: Neutrophils <1.5x109/L
Leukopenia: Leukocytes <3.0x109/L
Hypogammaglobulinemia: Serum immunoglobulins 5.0 g/L
Secondary cause of MN (e.g. Systemic lupus erythematosus, medications, malignancies)
Concomitant renal disease other than MN (e.g., diabetic renal disease, lupus nephritis, IgA nephropathy)
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.
Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more
Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more
Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study

user name

Annotated by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No made yet