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

June 12, 2020 updated by: Alnylam Pharmaceuticals
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.

Study Overview

Status

Terminated

Conditions

Detailed Description

Refer to www.studyALECT2.com

Study Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Clinical Trial Site
      • Assiut, Egypt
        • Clinical Trial Site
      • Cairo, Egypt
        • Clinical Trial Site
      • Mansoura City, Egypt
        • Clinical Trial Site
  • India
      • 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
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Clinical Trial Site
  • Mexico
      • Monterrey, Mexico
        • Clinical Trial Site
    • Baja
      • Mexicali, Baja, Mexico, 21200
        • Clinical Trial Site
    • Mexico DF
      • Mexico, Mexico DF, Mexico, 14080
        • Clinical Trial Site
    • Sinaloa
      • Culiacán, Sinaloa, Mexico, 80230
        • Clinical Trial Site
  • United Kingdom
      • London, United Kingdom
        • Clinical Trial Site
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Clinical Trial Site
      • Tucson, Arizona, United States, 85724
        • Clinical Trial Site
    • Colorado
      • Denver, Colorado, United States, 80210
        • Clinical Trial Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Clinical Trial Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Clinical Trial Site
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Clinical Trial Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Clinical Trial Site
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Clinical Trial Site
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Clinical Trial Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Clinical Trial Site
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Clinical Trial Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Clinical Trial Site
    • Texas
      • Houston, Texas, United States, 77030
        • Clinical Trial Site
      • Houston, Texas, United States, 77004
        • Clinical Trial Site
      • San Antonio, Texas, United States, 78212
        • Clinical Trial Site
    • Utah
      • Saint George, Utah, United States, 84790
        • Clinical Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants with biopsy-proven ALECT2.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
ALECT2 Disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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)
From baseline to end of study (Month 48)

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
Baseline (Day 1), Months 12, 24, 36 and 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alnylam Pharmaceuticals

Investigators

  • Study Director: Joshua Friedman, MD, Alnylam Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 29, 2019

Primary Completion (ACTUAL)

May 18, 2020

Study Completion (ACTUAL)

May 18, 2020

Study Registration Dates

First Submitted

December 11, 2018

First Submitted That Met QC Criteria

December 11, 2018

First Posted (ACTUAL)

December 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 12, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALN-LECT2-NT-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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