REFLECTION is a “natural history” study being conducted to observe and collect information about Leukocyte Chemotactic Factor 2 amyloidosis, also called ALECT2 or ALECT2 amyloidosis. ALECT2 is a rare and quite recently discovered disease. Researchers are working to learn everything they can about the disease in order to better understand how to diagnose, treat, and care for patients who suffer from it.
What Is a “natural history” study?
A natural history study is a clinical study that follows a group of people over time who have, or may develop, a specific medical condition. Study participants are monitored and information that is collected helps researchers better understand the condition. In a natural history study, no study medication is administered to the participants. The purpose of the study is simply to learn as much as possible about the condition, including the effectiveness of any current treatments, as participants go about their daily lives.
Find out if you qualify for the REFLECTION study
What are we trying to learn about ALECT2 in REFLECTION?
ALECT2 is a recently discovered and very rare condition, with the first case being identified in 2008. This does not mean that people did not get ALECT2 before 2008, just that it was not recognized by doctors before that time. REFLECTION researchers are trying to learn as much as possible about ALECT2, including:
- How quickly the kidney disease caused by ALECT2 progresses (gets worse), and what factors influence that progression
- Identification of specific indicators (called ‘biomarkers’) detectable in blood and urine that may help future diagnosis and the development of treatments
- Other diseases or conditions that may be associated with ALECT2
- The impact of ALECT2 on people’s quality of life and general health status
Why should individuals with ALECT2 consider participating in the REFLECTION study?
The recent discovery of ALECT2 means that little is known about the long-term evolution of symptoms over time, and there are very limited treatment options. REFLECTION will help researchers learn more about this rare condition, including how it affects the body over time, so they can potentially develop better ways to diagnose and treat the condition.
Who can participate in the REFLECTION study, and what is involved?
Up to 150 adults who have been diagnosed with ALECT2 will take part in this study.
- Diagnosis of ALECT2 must have been confirmed by a kidney biopsy.
- If you do not have a diagnosis but your doctor thinks your kidney disease may be caused by ALECT2, diagnosis may be confirmed as part of this study.
What taking part involves depends on how severe your kidney disease is when you join the study:
Where is the study being conducted?
The REFLECTION study will be conducted globally in the following countries:
- United States
- United Kingdom
Travel assistance within a country may be available for participants who qualify for the study but do not live near a study center.
Additional information can be found at https://clinicaltrials.gov/ct2/show/NCT03774784.