A Study of the Natural History of Leukocyte Chemotactic Factor 2 Amyloidosis (ALECT2) Disease
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ClinicalTrials.gov Identifier: NCT03774784 |
Recruitment Status :
Terminated
(The study was terminated due to the impacts of COVID-19 on patient safety and enrollment.)
First Posted : December 13, 2018
Last Update Posted : June 16, 2020
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Condition or disease |
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Amyloidosis Leukocyte Chemotactic Factor 2 Amyloidosis |
Study Type : | Observational |
Actual Enrollment : | 26 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | A Study of the Natural History of Leukocyte Chemotactic Factor 2 Amyloidosis (ALECT2) Disease |
Actual Study Start Date : | January 29, 2019 |
Actual Primary Completion Date : | May 18, 2020 |
Actual Study Completion Date : | May 18, 2020 |
Group/Cohort |
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ALECT2 Disease |
- 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) ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- There are no exclusion criteria for this observational study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774784
United States, Arizona | |
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Scottsdale, Arizona, United States, 85259 | |
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Tucson, Arizona, United States, 85724 | |
United States, Colorado | |
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Denver, Colorado, United States, 80210 | |
United States, Illinois | |
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Chicago, Illinois, United States, 60611 | |
United States, Indiana | |
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Indianapolis, Indiana, United States, 46202 | |
United States, Maryland | |
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Baltimore, Maryland, United States, 21205 | |
United States, Massachusetts | |
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Boston, Massachusetts, United States, 02118 | |
United States, Michigan | |
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Detroit, Michigan, United States, 48201 | |
United States, Minnesota | |
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Rochester, Minnesota, United States, 55902 | |
United States, New Mexico | |
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Albuquerque, New Mexico, United States, 87106 | |
United States, Ohio | |
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Columbus, Ohio, United States, 43210 | |
United States, Oregon | |
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Portland, Oregon, United States, 97239 | |
United States, Texas | |
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Houston, Texas, United States, 77004 | |
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Houston, Texas, United States, 77030 | |
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San Antonio, Texas, United States, 78212 | |
United States, Utah | |
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Saint George, Utah, United States, 84790 | |
Egypt | |
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Alexandria, Egypt | |
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Assiut, Egypt | |
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Cairo, Egypt | |
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Mansoura City, Egypt | |
India | |
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Chandigarh, India | |
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Ludhiāna, India | |
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Manipal, India | |
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Nadiād, India | |
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Tamil Nadu, India | |
Malaysia | |
Clinical Trial Site | |
Kuala Lumpur, Malaysia | |
Mexico | |
Clinical Trial Site | |
Mexicali, Baja, Mexico, 21200 | |
Clinical Trial Site | |
Mexico, Mexico DF, Mexico, 14080 | |
Clinical Trial Site | |
Culiacán, Sinaloa, Mexico, 80230 | |
Clinical Trial Site | |
Monterrey, Mexico | |
United Kingdom | |
Clinical Trial Site | |
London, United Kingdom |
Study Director: | Joshua Friedman, MD | Alnylam Pharmaceuticals |
Responsible Party: | Alnylam Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT03774784 |
Other Study ID Numbers: |
ALN-LECT2-NT-001 |
First Posted: | December 13, 2018 Key Record Dates |
Last Update Posted: | June 16, 2020 |
Last Verified: | June 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Amyloidosis Proteostasis Deficiencies Metabolic Diseases |