AngioedemaKALANNCT04597944
Lanadelumab in Bradykinin Angioedema
An observational study of Angioedema, run by University Hospital, Grenoble at 2 sites in France.
Trial summary
A multicenter observational study aiming to evaluate the efficacy of kallikrein inhibition by lanadelumab in patients with bradykinin- angioedema Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angioedema
- How many people
- 80 participants
- Where
- 2 sitesFrance
- Study dates
- 18 Sep 2020to Sep 2025
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hereditary or Acquired Angiodema
Who may be able to join
- 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
Who cannot join
- Absence of biological material at T0 and M3 (stored for routine analysis)
- Person under guardianship or curatorship
- Female who is pregnant, nursing
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Chu Grenoble Alpes
Grenoble, 38043
Frédérica DEFENDI, +33 (0)4 76 76 54 16, fdefendi@chu-grenoble.fr
- Recruiting
CHU Rouen
Rouen
Sébastien MIRANDA, +33 (0)2 32 88 90 01, Sebastien.Miranda@chu-rouen.fr
About this study
Official title: Evaluation of the Efficacy of Kallikrein Inhibition by Lanadelumab for Patients With Bradykinin Angioedema: a Cohort Study
A multicenter observational study aiming to evaluate the efficacy of kallikrein inhibition by lanadelumab in patients with bradykinin- angioedema
Read the detailed description
The bradykinin-angioedema (AE-BK) is characterized by recurrent and unpredictable episodes of swelling; it can be disabling and disfiguring and the attacks affecting the larynx can be life-threatening.
The clinical symptoms depend on accumulation of bradykinin (BK), a vasoactive peptide responsible for vasodilation and increase of vascular leakage. BK formation depends on activation of the kallikrein-kinin cascade leading to uncontrolled generation of plasma kallikrein and subsequent proteolysis of high molecular-weight kininogen (HK).
Lanadelumab is a fully human monoclonal antibody inhibitor of plasma kallikrein, thereby preventing BK production; it represents an attractive therapeutic strategy for BK-AE prophylaxis.
The aim of this study is to evaluate the kallikrein inhibition by assessing the levels of cleaved HK and the immunogenicity of the lanadelumab.
- Conditions
- Angioedema
- Keywords
- Kallikrein, Kininogen, Bradykinin, Lanadelumab
- Medical subject headings
- Angioedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Hereditary or Acquired Angioedema | Participants older than 18 years that are diagnosed with Hereditary or Acquired Angioedema and treated by lanadelumab. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the efficacy of the kallikrein inhibition by lanadelumab in patients with bradykinin-angioedema
Levels of cleaved HK measured by Western Blot
Measured: 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
Levels of cleaved HK as measured by Western Blot Ratio Day 7/ Day 0, Ratio Month 6/ Day 0, Ratio Month 12/ Day (and if possible Month 24/ Day 0) of the levels of cleaved HK as measured by Western Blot
- SE2: antidrug antibodies in the sera of patients at Months 3, 6, 12 (and if possible Month 24).
Measured: Day 7; 6, 12 and if possible 24 months
Immunogenicity of lanadelumab
Levels of antidrug antibodies in the sera of patients
Measured: Months 3, 6, 12 (and 24 if possible)
Evaluation of therapeutic escape
Increase/absence of decrease of the number of attacks during lanadelumab administration
Measured: Months 3, 6, 12 and if possible 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start18 Sep 2020
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AngioedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Federica DEFENDI, Principal investigator, Grenoble Alpes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597944
- Sponsor's protocol ID
- 38RC20.187
- Other IDs
- 2020-A01528-31
- Acronym
- KALAN
- Status last verified
- Mar 2024
- First submitted
- 14 Sep 2020
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Kallikrein Inhibition by Lanadelumab for Patients With Bradykinin Angioedema: a Cohort Study
- ClinicalTrials.gov ID
- NCT04597944
- Acronym / sponsor ID
- KALAN / 38RC20.187
- Conditions
- Angioedema
- Keywords
- Kallikrein, Kininogen, Bradykinin, Lanadelumab
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter observational study aiming to evaluate the efficacy of kallikrein inhibition by lanadelumab in patients with bradykinin- angioedema
Detailed description
The bradykinin-angioedema (AE-BK) is characterized by recurrent and unpredictable episodes of swelling; it can be disabling and disfiguring and the attacks affecting the larynx can be life-threatening.
The clinical symptoms depend on accumulation of bradykinin (BK), a vasoactive peptide responsible for vasodilation and increase of vascular leakage. BK formation depends on activation of the kallikrein-kinin cascade leading to uncontrolled generation of plasma kallikrein and subsequent proteolysis of high molecular-weight kininogen (HK).
Lanadelumab is a fully human monoclonal antibody inhibitor of plasma kallikrein, thereby preventing BK production; it represents an attractive therapeutic strategy for BK-AE prophylaxis.
The aim of this study is to evaluate the kallikrein inhibition by assessing the levels of cleaved HK and the immunogenicity of the lanadelumab.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Hereditary or Acquired Angioedema | – | –Participants older than 18 years that are diagnosed with Hereditary or Acquired Angioedema and treated by lanadelumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hereditary or Acquired Angiodema
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Absence of biological material at T0 and M3 (stored for routine analysis)
- Person under guardianship or curatorship
- Female who is pregnant, nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of the efficacy of the kallikrein inhibition by lanadelumab in patients with bradykinin-angioedema
Time frame: 3 months
Levels of cleaved HK measured by Western Blot
3 secondary outcomes
Evaluation of the efficacy of kallikrein inhibition by lanadelumab in patients with bradykinin-angioedema between T0 and the others visits
Time frame: Day 7; 6, 12 and if possible 24 months
Immunogenicity of lanadelumab
Time frame: Months 3, 6, 12 (and 24 if possible)
Evaluation of therapeutic escape
Time frame: Months 3, 6, 12 and if possible 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Federica DEFENDI principal investigator
Grenoble Alpes University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angioedema, run by University Hospital, Grenoble at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Federica Defendi, PhD (+330476765416, fdefendi@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the efficacy of the kallikrein inhibition by lanadelumab in patients with bradykinin-angioedema (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.