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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
Sponsor:
Information provided by (Responsible Party):
Alnylam Pharmaceuticals

Study Description
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Brief 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. 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.

Condition or disease
Amyloidosis Leukocyte Chemotactic Factor 2 Amyloidosis

Detailed Description:
Refer to www.studyALECT2.com
Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis

Groups and Cohorts
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Group/Cohort
ALECT2 Disease


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Time to End-Stage Renal Disease (ESRD) [ Time Frame: From baseline to end of study (Month 48) ]

Secondary Outcome Measures :
  1. 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 ]
  2. Level of LECT2 mRNA in Urine [ Time Frame: Baseline (Day 1), Months 12, 24, 36 and 48 ]
  3. Level of LECT2 Protein in Blood [ Time Frame: Baseline (Day 1), Months 6, 12, 18, 24, 30, 36, 42 and 48 ]
  4. Level of LECT2 Protein in Urine [ Time Frame: Baseline (Day 1), Months 12, 24, 36 and 48 ]
  5. Percentage of Participants With Proteinuria [ Time Frame: Baseline (Day 1), Months 12, 24, 36 and 48 ]

Eligibility Criteria
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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
Study Population
Participants with biopsy-proven ALECT2.
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Arizona
Clinical Trial Site
Scottsdale, Arizona, United States, 85259
Clinical Trial Site
Tucson, Arizona, United States, 85724
United States, Colorado
Clinical Trial Site
Denver, Colorado, United States, 80210
United States, Illinois
Clinical Trial Site
Chicago, Illinois, United States, 60611
United States, Indiana
Clinical Trial Site
Indianapolis, Indiana, United States, 46202
United States, Maryland
Clinical Trial Site
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Clinical Trial Site
Boston, Massachusetts, United States, 02118
United States, Michigan
Clinical Trial Site
Detroit, Michigan, United States, 48201
United States, Minnesota
Clinical Trial Site
Rochester, Minnesota, United States, 55902
United States, New Mexico
Clinical Trial Site
Albuquerque, New Mexico, United States, 87106
United States, Ohio
Clinical Trial Site
Columbus, Ohio, United States, 43210
United States, Oregon
Clinical Trial Site
Portland, Oregon, United States, 97239
United States, Texas
Clinical Trial Site
Houston, Texas, United States, 77004
Clinical Trial Site
Houston, Texas, United States, 77030
Clinical Trial Site
San Antonio, Texas, United States, 78212
United States, Utah
Clinical Trial Site
Saint George, Utah, United States, 84790
Egypt
Clinical Trial Site
Alexandria, Egypt
Clinical Trial Site
Assiut, Egypt
Clinical Trial Site
Cairo, Egypt
Clinical Trial Site
Mansoura City, Egypt
India
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
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
Sponsors and Collaborators
Alnylam Pharmaceuticals
Investigators
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Study Director: Joshua Friedman, MD Alnylam Pharmaceuticals
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases