A Study of the Natural History of Leukocyte Chemotactic Factor 2 Amyloidosis (ALECT2) Disease

NCT ID: NCT03774784

Last Updated: 2020-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-29

Study Completion Date

2020-05-18

Brief Summary

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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.

Detailed Description

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Refer to www.studyALECT2.com

Conditions

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Amyloidosis Leukocyte Chemotactic Factor 2 Amyloidosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ALECT2 Disease

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alnylam Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joshua Friedman, MD

Role: STUDY_DIRECTOR

Alnylam Pharmaceuticals

Locations

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Clinical Trial Site

Scottsdale, Arizona, United States

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Tucson, Arizona, United States

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Denver, Colorado, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Detroit, Michigan, United States

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Rochester, Minnesota, United States

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Albuquerque, New Mexico, United States

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Columbus, Ohio, United States

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Portland, Oregon, United States

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Houston, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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St. George, Utah, United States

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Al Mansurah, , Egypt

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Alexandria, , Egypt

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Asyut, , Egypt

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Cairo, , Egypt

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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

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Kuala Lumpur, , Malaysia

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Mexicali, Baja, Mexico

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México, Mexico DF, Mexico

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Culiacán, Sinaloa, Mexico

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Monterrey, , Mexico

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London, , United Kingdom

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Countries

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United States Egypt India Malaysia Mexico United Kingdom

Other Identifiers

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ALN-LECT2-NT-001

Identifier Type: -

Identifier Source: org_study_id

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