AmyloidosisNCT03774784
A Study of the Natural History of Leukocyte Chemotactic Factor 2 Amyloidosis (ALECT2) Disease
An observational study of Amyloidosis and Leukocyte Chemotactic Factor 2 Amyloidosis, run by Alnylam Pharmaceuticals at 31 sites in 6 countries.
Trial summary
The purpose of this study is to characterize the natural history of leukocyte chemotactic factor 2 amyloidotic (ALECT2) disease. In this observational study participants with ALECT2 disease will be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyloidosis, Leukocyte Chemotactic Factor 2 Amyloidosis
- How many people
- 26 participants
- Where
- 31 sitesin 6 countries
- Study dates
- 29 Jan 2019to 18 May 2020
- 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: Participants with biopsy-proven ALECT2.
Who may be able to join
- Males and females, age 18 years or older;
- Renal biopsy-proven diagnosis of ALECT2;
- For patients with kidney disease that could be due to ALECT2, a renal biopsy may be obtained to confirm ALECT2 diagnosis.
Who cannot join
- There are no exclusion criteria for this observational study.
Trial locations and contacts
31 sites in 6 countries.
31 sites in 6 countries
United States16 sites
Clinical Trial Site
Albuquerque, New Mexico, 87106
Clinical Trial Site
Baltimore, Maryland, 21205
Clinical Trial Site
Boston, Massachusetts, 02118
Clinical Trial Site
Chicago, Illinois, 60611
Clinical Trial Site
Columbus, Ohio, 43210
Clinical Trial Site
Denver, Colorado, 80210
Clinical Trial Site
Detroit, Michigan, 48201
Clinical Trial Site
Houston, Texas, 77004
Clinical Trial Site
Houston, Texas, 77030
Clinical Trial Site
Indianapolis, Indiana, 46202
Clinical Trial Site
Portland, Oregon, 97239
Clinical Trial Site
Rochester, Minnesota, 55902
Clinical Trial Site
San Antonio, Texas, 78212
Clinical Trial Site
Scottsdale, Arizona, 85259
Clinical Trial Site
St. George, Utah, 84790
Clinical Trial Site
Tucson, Arizona, 85724
India5 sites
Clinical Trial Site
Chandigarh
Clinical Trial Site
Ludhiāna
Clinical Trial Site
Manipal
Clinical Trial Site
Nadiād
Clinical Trial Site
Tamil Nadu
Egypt4 sites
Clinical Trial Site
Al Mansurah
Clinical Trial Site
Alexandria
Clinical Trial Site
Asyut
Clinical Trial Site
Cairo
Mexico4 sites
Clinical Trial Site
Culiacán, Sinaloa, 80230
Clinical Trial Site
Mexicali, Baja, 21200
Clinical Trial Site
México, Mexico DF, 14080
Clinical Trial Site
Monterrey
About this study
The purpose of this study is to characterize the natural history of leukocyte chemotactic factor 2 amyloidotic (ALECT2) disease. In this observational study participants with ALECT2 disease will be enrolled. Participants, who have already reached end-stage renal disease (ESRD), will provide retrospective chart review data and biological specimens at baseline only. Other participants, in addition to retrospective chart review, will be followed prospectively.
Read the detailed description
Refer to www.studyALECT2.com
- Medical subject headings
- Amyloidosis
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 |
|---|---|---|
| ALECT2 Disease | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Estimated Glomerular Filtration Rate (eGFR) from Baseline Up to End of Study (Month 48)
Measured: Baseline (Day 1), Months 6, 12, 18, 24, 30, 36, 42 and 48
Time to End-Stage Renal Disease (ESRD)
Measured: From baseline to end of study (Month 48)
Secondary outcomes (5)
Level of Leukocyte Chemotactic Factor 2 (LECT2) Messenger Ribonucleic Acid (mRNA) in Blood
Measured: Baseline (Day 1), Months 6, 12, 18, 24, 30, 36, 42 and 48
Level of LECT2 mRNA in Urine
Measured: Baseline (Day 1), Months 12, 24, 36 and 48
Level of LECT2 Protein in Blood
Measured: Baseline (Day 1), Months 6, 12, 18, 24, 30, 36, 42 and 48
Level of LECT2 Protein in Urine
Measured: Baseline (Day 1), Months 12, 24, 36 and 48
Percentage of Participants With Proteinuria
Measured: Baseline (Day 1), Months 12, 24, 36 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start29 Jan 2019
- Primary completion18 May 2020
- Study completion18 May 2020
Why it stopped: The study was terminated due to the impacts of COVID-19 on patient safety and enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmyloidosisStudies of the same condition, open and under way.
- More trials run by Alnylam PharmaceuticalsThe sponsor's other registered studies.
- 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alnylam Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joshua Friedman, MD, Study director, Alnylam Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774784
- Sponsor's protocol ID
- ALN-LECT2-NT-001
- Status last verified
- Jun 2020
- First submitted
- 11 Dec 2018
- Last updated
- 16 Jun 2020
- Results posted
- 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 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Natural History of Leukocyte Chemotactic Factor 2 Amyloidosis (ALECT2) Disease
- ClinicalTrials.gov ID
- NCT03774784
- Acronym / sponsor ID
- ALN-LECT2-NT-001
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated due to the impacts of COVID-19 on patient safety and enrollment.
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Alnylam PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 18 May 2020 (actual)
- Study completion
- 18 May 2020 (actual)
- First posted
- 13 Dec 2018 (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.
The purpose of this study is to characterize the natural history of leukocyte chemotactic factor 2 amyloidotic (ALECT2) disease. In this observational study participants with ALECT2 disease will be enrolled. Participants, who have already reached end-stage renal disease (ESRD), will provide retrospective chart review data and biological specimens at baseline only. Other participants, in addition to retrospective chart review, will be followed prospectively.
Detailed description
Refer to www.studyALECT2.com
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALECT2 Disease | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with biopsy-proven ALECT2.
Key inclusion criteria (3 listed)
- Males and females, age 18 years or older;
- Renal biopsy-proven diagnosis of ALECT2;
- For patients with kidney disease that could be due to ALECT2, a renal biopsy may be obtained to confirm ALECT2 diagnosis.
Key exclusion criteria (1 listed)
- There are no exclusion criteria for this observational study.
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
Change in Estimated Glomerular Filtration Rate (eGFR) from Baseline Up to End of Study (Month 48)
Time frame: Baseline (Day 1), Months 6, 12, 18, 24, 30, 36, 42 and 48
Time to End-Stage Renal Disease (ESRD)
Time frame: From baseline to end of study (Month 48)
5 secondary outcomes
Level of Leukocyte Chemotactic Factor 2 (LECT2) Messenger Ribonucleic Acid (mRNA) in Blood
Time frame: Baseline (Day 1), Months 6, 12, 18, 24, 30, 36, 42 and 48
Level of LECT2 mRNA in Urine
Time frame: Baseline (Day 1), Months 12, 24, 36 and 48
Level of LECT2 Protein in Blood
Time frame: Baseline (Day 1), Months 6, 12, 18, 24, 30, 36, 42 and 48
Level of LECT2 Protein in Urine
Time frame: Baseline (Day 1), Months 12, 24, 36 and 48
Percentage of Participants With Proteinuria
Time frame: Baseline (Day 1), Months 12, 24, 36 and 48
Results and safety
The study was stopped early (reason given: The study was terminated due to the impacts of COVID-19 on patient safety and enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- 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.
Joshua Friedman, MD study director
Alnylam Pharmaceuticals
31 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyloidosis and Leukocyte Chemotactic Factor 2 Amyloidosis, run by Alnylam Pharmaceuticals at 31 sites in 6 countries.
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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, India, Egypt, Mexico, Malaysia and 1 more country. 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?
The study was stopped early (reason given: The study was terminated due to the impacts of COVID-19 on patient safety and enrollment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Estimated Glomerular Filtration Rate (eGFR) from Baseline Up to End of Study (Month 48) (time frame: Baseline (Day 1), Months 6, 12, 18, 24, 30, 36, 42 and 48). The study lists 2 primary outcomes in all. 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 16 Jun 2020.