Treatment of secondary renal amyloidosis A with the Intereleukin – 1 antagonist anakinra

Phase 1

• Conditions: Renal Amyloidosis

• Registration Number: EUCTR2007-005079-32-AT
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-10-31
• Last Update Posted: 26 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1.Biopsy proven renal amyoidosis
2.Serum Amyloid A concentration greater than 25mg/l
3.Estimated GFR between 30 to 90ml/min
4.Men or women aged >18years
5.Provision of informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Estimated GFR < 30ml/min
2.Kidney disease other than renal amyloidosis
3.Child bearing potential with lack of a reliable method of contraception.
4.Poor compliance
5.Medical history that might limit the individual’s ability to take the trial treatment for the duration of the study.
6.Simultanous administration of TNF-blocking agents (etanercept, adalimumab, and infliximab)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified