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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-005079-32-AT

Enrollment

Registered

2007-10-31

Start date

2007-12-04

Completion date

Unknown

Last updated

2020-10-26

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

Conditions

Renal Amyloidosis

Interventions

Trade Name: Kineret Product Name: Kineret Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
Main Objective: Outcome assessment at the end of the study The primary end point is measurement of kidney function by the estimated glomerular filtration rate and extent of proteinuria as 24h urinary excretion and fractional protein excretion. The results will be compared with the change of eGFR during the preceeding six months, and the mean of two protein excretion measurements at study entry. Progresssion of disease is defined as a significant more rapid decline of eGFR compared to pretreatment values, or a significant higher protein excretion. Improvement of both markers is defined as improvement of the disease, and no change as disease beeing stable. ;Secondary Objective: ;Primary end point(s): The primary end point is measurement of kidney function by the estimated glomerular filtration rate and extent of proteinuria as 24h urinary excretion and fractional protein excretion. The results will be compared with the change of eGFR during the preceeding six months, and the mean of two protein excretion measurements at study entry. Progresssion of disease is defined as a significant more rapid decline of eGFR compared to pretreatment values, or a significant higher protein excretion. Improvement of both markers is defined as improvement of the disease, and no change as disease beeing stable.	—

Measure

Time frame

Main Objective: Outcome assessment at the end of the study The primary end point is measurement of kidney function by the estimated glomerular filtration rate and extent of proteinuria as 24h urinary excretion and fractional protein excretion. The results will be compared with the change of eGFR during the preceeding six months, and the mean of two protein excretion measurements at study entry. Progresssion of disease is defined as a significant more rapid decline of eGFR compared to pretreatment values, or a significant higher protein excretion. Improvement of both markers is defined as improvement of the disease, and no change as disease beeing stable. ;Secondary Objective: ;Primary end point(s): The primary end point is measurement of kidney function by the estimated glomerular filtration rate and extent of proteinuria as 24h urinary excretion and fractional protein excretion. The results will be compared with the change of eGFR during the preceeding six months, and the mean of two protein excretion measurements at study entry. Progresssion of disease is defined as a significant more rapid decline of eGFR compared to pretreatment values, or a significant higher protein excretion. Improvement of both markers is defined as improvement of the disease, and no change as disease beeing stable.

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Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026