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| European trial of free light chain removal by extended haemodialysis in cast nephropathy |
| Source of record | UK Trials |
| ISRCTN | ISRCTN45967602 |
| Date ISRCTN assigned | 26/03/2008 |
| Local reference number(s) | 1.0 |
| Public title | European trial of free light chain removal by extended haemodialysis in cast nephropathy |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Multiple myeloma, acute renal failure and cast nephropathy |
| Study hypothesis | Free light removal by extended haemodialysis aids recovery of renal function in patients with cast nephropathy. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Ethics approval received from Central Office for Research Ethics Committees (COREC) on the 4th February 2008 (ref: 07/H1307/133). |
| Countries of trial | United Kingdom, Germany, Italy, Portugal |
| 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 |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Anticipated start date | 01/09/2007 |
| Anticipated end date | 01/09/2009 |
| Status of trial | Ongoing |
| 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) |
| Sponsor name | University Hospital Birmingham NHS Foundation Trust (UK) |
| Sponsor details | Queen Elizabeth Medical Centre Birmingham United Kingdom B15 2TH |
| Sponsor website | http://www2.uhb.nhs.uk/Homepage.aspx |
| Contact name | Dr Paul Cockwell |
| Contact details | Queen Elizabeth Medical Centre Birmingham United Kingdom B15 2TH |
| Contact telephone | +44 (0)121 472 1311 |
| Contact email | paul.cockwell@uhb.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN45967602 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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