Effects of Lixelle on amyloid bone cysts of dialysis patients

JRCT ID: jRCTs072180089

Registered date:29/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Dialysis amyloidosis
• Date of first enrollment: 12/07/2018
• Target sample size: 30
• Study type: Interventional

Intervention(s)

Treatment with each plan to following two groups divided by the intention of the patients.
Group A (15 patients) :start the Lixelle.
Group B (15 patients) :continue current dialysis.

Outcome(s)

• Primary Outcome: The change of cyst volume by HR-pQCT from the baseline to 12 months.

Secondary Outcome

1.The change of cyst by HR-pQCT from the baseline to 24 months.
2.The change of bone lesion by CT scan and the change of bone mineral density by QCT and HR-pQCT from the baseline to 24 months.
3.The change of bone lesion by simple roentgenography and marker for inflammatory condition and bone metabolism from the baseline to 12 and 24 months.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients with CKD who had been treated with HD for 10 years or more, and have carpal tunnel syndrome by dialysis amyloidosis.
A written informed consent for the participation in the study.

Exclude criteria

Patients treated by Denosmabu.
Patients judged to be inadequate for this study by investigators.

Related Information

• Primary Sponsor: Osaki Makoto
• Secondary Sponsor: Chiba Ko
• Source(s) of Monetary Support: Kaneka corporation
• Secondary ID(s): UMIN000031876