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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date December 11, 2018
First Posted Date December 13, 2018
Last Update Posted Date June 16, 2020
Actual Study Start Date January 29, 2019
Actual Primary Completion Date May 18, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 11, 2018)
  • 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) ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 11, 2018)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study of the Natural History of Leukocyte Chemotactic Factor 2 Amyloidosis (ALECT2) Disease
Official Title A Study of the Natural History of Leukocyte Chemotactic Factor 2 Amyloidosis (ALECT2) Disease
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.
Detailed Description Refer to www.studyALECT2.com
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Participants with biopsy-proven ALECT2.
Condition
  • Amyloidosis
  • Leukocyte Chemotactic Factor 2 Amyloidosis
Intervention Not Provided
Study Groups/Cohorts ALECT2 Disease
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: June 12, 2020)
26
Original Estimated Enrollment
 (submitted: December 11, 2018)
150
Actual Study Completion Date May 18, 2020
Actual Primary Completion Date May 18, 2020   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Egypt,   India,   Malaysia,   Mexico,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03774784
Other Study ID Numbers ALN-LECT2-NT-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Alnylam Pharmaceuticals
Study Sponsor Alnylam Pharmaceuticals
Collaborators Not Provided
Investigators
Study Director: Joshua Friedman, MD Alnylam Pharmaceuticals
PRS Account Alnylam Pharmaceuticals
Verification Date June 2020