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The study was terminated due to the impacts of COVID-19 on patient safety and enrollment.
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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.
Refer to www.studyALECT2.com
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALECT2 Disease |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Estimated Glomerular Filtration Rate (eGFR) from Baseline Up to End of Study (Month 48) | Baseline (Day 1), Months 6, 12, 18, 24, 30, 36, 42 and 48 | |
| Time to End-Stage Renal Disease (ESRD) | From baseline to end of study (Month 48) |
| Measure | Description | Time Frame |
|---|---|---|
| Level of Leukocyte Chemotactic Factor 2 (LECT2) Messenger Ribonucleic Acid (mRNA) in Blood | Baseline (Day 1), Months 6, 12, 18, 24, 30, 36, 42 and 48 | |
| Level of LECT2 mRNA in Urine | Baseline (Day 1), Months 12, 24, 36 and 48 |
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Inclusion Criteria:
Exclusion Criteria:
- There are no exclusion criteria for this observational study.
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Participants with biopsy-proven ALECT2.
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| Name | Affiliation | Role |
|---|---|---|
| Joshua Friedman, MD | Alnylam Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Scottsdale | Arizona | 85259 | United States | ||
| Clinical Trial Site |
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| Level of LECT2 Protein in Blood | Baseline (Day 1), Months 6, 12, 18, 24, 30, 36, 42 and 48 |
| Level of LECT2 Protein in Urine | Baseline (Day 1), Months 12, 24, 36 and 48 |
| Percentage of Participants With Proteinuria | Baseline (Day 1), Months 12, 24, 36 and 48 |
| Tucson |
| Arizona |
| 85724 |
| United States |
| Clinical Trial Site | Denver | Colorado | 80210 | United States |
| Clinical Trial Site | Chicago | Illinois | 60611 | United States |
| Clinical Trial Site | Indianapolis | Indiana | 46202 | United States |
| Clinical Trial Site | Baltimore | Maryland | 21205 | United States |
| Clinical Trial Site | Boston | Massachusetts | 02118 | United States |
| Clinical Trial Site | Detroit | Michigan | 48201 | United States |
| Clinical Trial Site | Rochester | Minnesota | 55902 | United States |
| Clinical Trial Site | Albuquerque | New Mexico | 87106 | United States |
| Clinical Trial Site | Columbus | Ohio | 43210 | United States |
| Clinical Trial Site | Portland | Oregon | 97239 | United States |
| Clinical Trial Site | Houston | Texas | 77004 | United States |
| Clinical Trial Site | Houston | Texas | 77030 | United States |
| Clinical Trial Site | San Antonio | Texas | 78212 | United States |
| Clinical Trial Site | St. George | Utah | 84790 | United States |
| Clinical Trial Site | Al Mansurah | Egypt |
| Clinical Trial Site | Alexandria | Egypt |
| Clinical Trial Site | Asyut | Egypt |
| Clinical Trial Site | Cairo | Egypt |
| Clinical Trial Site | Chandigarh | India |
| Clinical Trial Site | Ludhiāna | India |
| Clinical Trial Site | Manipal | India |
| Clinical Trial Site | Nadiād | India |
| Clinical Trial Site | Tamil Nadu | India |
| Clinical Trial Site | Kuala Lumpur | Malaysia |
| Clinical Trial Site | Mexicali | Baja | 21200 | Mexico |
| Clinical Trial Site | México | Mexico DF | 14080 | Mexico |
| Clinical Trial Site | Culiacán | Sinaloa | 80230 | Mexico |
| Clinical Trial Site | Monterrey | Mexico |
| Clinical Trial Site | London | United Kingdom |
| ID | Term |
|---|---|
| D000686 | Amyloidosis |
| ID | Term |
|---|---|
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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