European trial of free light chain removal by extended haemodialysis in cast nephropathy
| ISRCTN | ISRCTN45967602 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45967602 |
| ClinicalTrials.gov (NCT) | NCT00700531 |
| Clinical Trials Information System (CTIS) | 2007-003968-22 |
| Protocol serial number | 1.0 |
| Sponsor | University Hospital Birmingham NHS Foundation Trust (UK) |
| Funder | Gambro Dialysatoren GmbH (Germany) (ref: study number 1454) |
- Submission date
- 10/07/2007
- Registration date
- 26/03/2008
- Last edited
- 19/03/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Colin Hutchison
Scientific
Scientific
Queen Elizabeth Medical Centre
Birmingham
B15 2TH
United Kingdom
| Phone | +44 (0)121 472 1311 |
|---|---|
| c.a.hutchison@bham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | European trial of free light chain removal by extended haemodialysis in cast nephropathy |
| Study acronym | EuLITE |
| Study objectives | Free light removal by extended haemodialysis aids recovery of renal function in patients with cast nephropathy. On 29/01/10 Denmark was added and Italy and Poland removed from the countries of recruitment. The overall trial end date was extended from 01/09/09 to 01/01/2012. On 12/04/2011 the overall trial end date for this trial was extended from 01/01/2012 to 31/12/2014. Denmark was removed from the countries of recruitment. |
| Ethics approval(s) | Central Office for Research Ethics Committees (COREC), 04/02/2008, ref: 07/H1307/133 |
| Health condition(s) or problem(s) studied | Multiple myeloma, acute renal failure and cast nephropathy |
| Intervention | All patients will receive standardised chemotherapy (velcade based regime). At enrolment the patients are randomised to receive either standard dialysis or free light chain (FLC) removal haemodialysis. FLC removal HD is undertaken using the Gambro HCO 1100 dialyser. Dialysis sessions are longer (8 hours versus 4 hours) and more frequent than the conventional dialysis received by the control arm. Standard dialysis (control arm) is that used for the management of patients with acute renal failure 4 hours, three times per week. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Velcade-based chemotherapy |
| Primary outcome measure(s) |
Independence of haemodialysis, at three months from enrolment. |
| Key secondary outcome measure(s) |
1. Investigation of the efficiency of extended haemodialysis (HD) using the Gambro HCO 1100 to result in sustained reductions in sFLC concentrations versus a standard dialysis at days 5, 12 and 21 |
| Completion date | 31/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 90 |
| Key inclusion criteria | 1. Dialysis dependent acute renal failure (estimated glomerular filtration rate [eGFR] less than 15 ml/min/1.73 m^2) 2. Fulfils diagnostic criteria for the diagnosis of symptomatic de novo multiple myeloma 3. Abnormal serum free light chain (FLC) ratio 4. Myeloma kidney demonstrated on a renal biopsy (cast nephropathy) 5. Ability to give informed consent to partake in study 6. Aged 18 years or older, either sex |
| Key exclusion criteria | 1. Known advanced chronic renal failure (chronic kidney disease [CKD] stage IV; eGFR less than 30 ml/min/1.73 m^2) or evidence of significant chronic damage on renal biopsy 2. Amyloidosis or light chain deposition disease on renal biopsy 3. Previous treatment of multiple myeloma with chemotherapy 4. Haemodynamic instability that precludes unsupported dialysis 5. Significant cardiac disease: 5.1. Myocardial infarction within six months 5.2. Unstable angina 5.3. New York Heart Association (NYHA) class III or IV heart failure 5.4. Clinically significant pericardial disease 5.5. Cardiac amyloidosis 6. Advanced disease or significant co-morbidity with poor short term prognosis, necessitating palliation and no active or disease specific treatment 7. Inability to give informed consent 8. History of allergic reaction to compounds containing boron or mannitol 9. History of peripheral neuropathy or neuropathic pain (grade two or higher) 10. Clinically significant liver dysfunction (bilirubin greater than 1.8 mg/dl [30 umol/L]) 11. Known human immunodeficiency virus (HIV) infection 12. Active uncontrolled infection 13. Pregnant/lactating women |
| Date of first enrolment | 01/09/2007 |
| Date of final enrolment | 31/12/2012 |
Locations
Countries of recruitment
- United Kingdom
- England
- Germany
Study participating centre
Queen Elizabeth Medical Centre
Birmingham
B15 2TH
United Kingdom
B15 2TH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2019 | Yes | No | |
| Protocol article | protocol | 28/09/2008 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/03/2020: EudraCT number added.
18/03/2019: Publication reference added.
29/10/2018: The publication and dissemination plan was updated.
