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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03774784

Enrollment

Registered

2018-12-13

Start date

2019-01-29

Completion date

2020-05-18

Last updated

2020-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyloidosis, Leukocyte Chemotactic Factor 2 Amyloidosis

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Level of LECT2 Protein in Blood	Baseline (Day 1), Months 6, 12, 18, 24, 30, 36, 42 and 48
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
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
Level of LECT2 mRNA in Urine	Baseline (Day 1), Months 12, 24, 36 and 48

Countries

Egypt, India, Malaysia, Mexico, United Kingdom, United States

Outcome results