European Trial of Free Light Chain Removal by Extended Haemodialysis in Cast Nephropathy - Free light chain removal by extended haemodialysis.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-003968-22-GB

Enrollment

Registered

2008-02-25

Start date

2008-02-04

Completion date

Unknown

Last updated

2019-06-30

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

Conditions

Multiple myeloma patients with acute dialysis dependent renal failure resulting from cast nephropathy. MedDRA version: 14.0 Level: LLT Classification code 10028566 Term: Myeloma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.0 Level: LLT Classification code 10028569 Term: Myelomato

Interventions

Trade Name: Velcade Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Bortezomib CAS Number: 179324-69-7 Curre

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Dialysis dependent acute renal failure (eGFR =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Known advanced chronic renal failure (CKD stage IV; eGFR 1.8mg/dl (30umol/L) • Known HIV infection • Active uncontrolled infection * Pregnant and lactating women

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to address the hypothesis that extended HD, using the Gambro HCO 1100, increases the percentage of patients with cast nephropathy becoming independent of dialysis.; Secondary Objective: 1. Investigation of the efficiency of extended HD using the Gambro HCO 1100 to result in sustained reductions in sFLC concentrations versus a standard dialysis. 2 Comparison of the duration of HD before renal recovery 3 Investigation of multiple myeloma response to chemotherapy and suitability for stem cell transplantation. 4 Mortality ;Primary end point(s): The primary analysis for the trial is to compare the experimental treatment to the control treatment in terms of independence of dialysis at three months. The proportion of patients independent of dialysis will be compared using relative risks and chi-square tests. The analysis will be carried out on an intention-to-treat basis.	—

Measure

Time frame

Main Objective: The primary objective of the study is to address the hypothesis that extended HD, using the Gambro HCO 1100, increases the percentage of patients with cast nephropathy becoming independent of dialysis.; Secondary Objective: 1. Investigation of the efficiency of extended HD using the Gambro HCO 1100 to result in sustained reductions in sFLC concentrations versus a standard dialysis. 2 Comparison of the duration of HD before renal recovery 3 Investigation of multiple myeloma response to chemotherapy and suitability for stem cell transplantation. 4 Mortality ;Primary end point(s): The primary analysis for the trial is to compare the experimental treatment to the control treatment in terms of independence of dialysis at three months. The proportion of patients independent of dialysis will be compared using relative risks and chi-square tests. The analysis will be carried out on an intention-to-treat basis.

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Countries

Germany, United Kingdom

Outcome results

None listed

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