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12 May 2008
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| [ Print-friendly version ] |
| European trial of free light chain removal by extended haemodialysis in cast nephropathy |
| ISRCTN | ISRCTN45967602 |
| ClinicalTrials.gov identifier | |
| Public title | European trial of free light chain removal by extended haemodialysis in cast nephropathy |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | 1.0 |
| Study hypothesis | Free light removal by extended haemodialysis aids recovery of renal function in patients with cast nephropathy. |
| Ethics approval | Ethics approval received from Central Office for Research Ethics Committees (COREC) on the 4th February 2008 (ref: 07/H1307/133). |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom, Germany, Italy, Portugal |
| Disease/condition/study domain | Multiple myeloma, acute renal failure and cast nephropathy |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/09/2007 |
| Anticipated end date | 01/09/2009 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 90 |
| Interventions | 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. |
| Primary outcome measure(s) | Independence of haemodialysis, at three months from enrolment. |
| 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
2. Comparison of the duration of HD before renal recovery 3. Investigation of multiple myeloma response to chemotherapy and suitability for stem cell transplantation at monthly intervals 4. Mortality, using Kaplan-Meier analysis |
| Sources of funding | Gambro Dialysatoren GmbH (Germany) (ref: study number 1454) |
| Trial website | |
| Publications | |
| Contact name | Dr Paul Cockwell |
| Address | Queen Elizabeth Medical Centre |
| City/town | Birmingham |
| Zip/Postcode | B15 2TH |
| Country | United Kingdom |
| Tel | +44 (0)121 472 1311 |
| paul.cockwell@uhb.nhs.uk | |
| Sponsor | University Hospital Birmingham NHS Foundation Trust (UK) |
| Address | Queen Elizabeth Medical Centre |
| City/town | Birmingham |
| Zip/Postcode | B15 2TH |
| Country | United Kingdom |
| Sponsor website: | http://www2.uhb.nhs.uk/Homepage.aspx |
| Date applied | 10/07/2007 |
| Last edited | 27/03/2008 |
| Date ISRCTN assigned | 26/03/2008 |
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