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

Terminated

• Conditions: Amyloidosis; Leukocyte Chemotactic Factor 2 Amyloidosis

• Registration Number: NCT03774784
• Lead Sponsor: Alnylam Pharmaceuticals

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 Timeline

• Study First Submitted: 2018-12-11
• Study First Submitted QC: 2018-12-11
• Study First Posted: 2018-12-13
• Study Start: 2019-01-29
• Primary Completion: 2020-05-18
• Study Completion: 2020-05-18
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-12
• Last Update Posted: 2020-06-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to End-Stage Renal Disease (ESRD)	From baseline to end of study (Month 48)
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

Secondary Outcome Measures

Name	Time	Method
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
Level of LECT2 Protein in Blood	Baseline (Day 1), Months 6, 12, 18, 24, 30, 36, 42 and 48
Percentage of Participants With Proteinuria	Baseline (Day 1), Months 12, 24, 36 and 48
Level of LECT2 Protein in Urine	Baseline (Day 1), Months 12, 24, 36 and 48

Trial Locations

Locations (1)

Clinical Trial Site; 🇬🇧 London, United Kingdom