Lanadelumab in Bradykinin Angioedema
KALAN
Evaluation of the Efficacy of Kallikrein Inhibition by Lanadelumab for Patients With Bradykinin Angioedema: a Cohort Study
2 other identifiers
observational
80
1 country
2
Brief Summary
A multicenter observational study aiming to evaluate the efficacy of kallikrein inhibition by lanadelumab in patients with bradykinin- angioedema
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2020
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2020
CompletedStudy Start
First participant enrolled
September 18, 2020
CompletedFirst Posted
Study publicly available on registry
October 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedMarch 19, 2024
March 1, 2024
5 years
September 14, 2020
March 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of the efficacy of the kallikrein inhibition by lanadelumab in patients with bradykinin-angioedema
Levels of cleaved HK measured by Western Blot
3 months
Secondary Outcomes (3)
Evaluation of the efficacy of kallikrein inhibition by lanadelumab in patients with bradykinin-angioedema between T0 and the others visits
Day 7; 6, 12 and if possible 24 months
Immunogenicity of lanadelumab
Months 3, 6, 12 (and 24 if possible)
Evaluation of therapeutic escape
Months 3, 6, 12 and if possible 24
Study Arms (1)
Participants with Hereditary or Acquired Angioedema
Participants older than 18 years that are diagnosed with Hereditary or Acquired Angioedema and treated by lanadelumab.
Eligibility Criteria
Hereditary or Acquired Angiodema
You may qualify if:
- Male/female \>18 years old
- Patient with hereditary or acquired angioedema
- Patient treated by lanadelumab
- Patient whose the biological explorations have been carried out or will be carried out at Laboratory of Immunology of CHUGA
- Informed consent is obtained from the participant
You may not qualify if:
- Absence of biological material at T0 and M3 (stored for routine analysis)
- Person under guardianship or curatorship
- Female who is pregnant, nursing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Chu Grenoble Alpes
Grenoble, 38043, France
CHU Rouen
Rouen, France
Biospecimen
Whole blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Federica DEFENDI
Grenoble Alpes University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 24 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2020
First Posted
October 22, 2020
Study Start
September 18, 2020
Primary Completion
September 1, 2025
Study Completion
September 1, 2025
Last Updated
March 19, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share