The following information will tell you about the research that is taking place in Cardiff, why it is happening, what is happening and most importantly your role and rights.
Over the past decade research developments, in terms of patient care delivery, have steadily increased mainly through the launching of the NHS Research and Development Strategy in 1991. This strategy has ensured that research-based knowledge is central to initiatives for patient centred services, clinical effectiveness and clinical audit. The 1997 NHS White Paper, ‘Putting Patients First’ identified patient centred services as central to the establishment of a National Service Framework which will offer evidence based frameworks for major care areas and disease groups such as kidney disease.
In other words, in order to give the highest quality treatment and care we need to be able to prove that what we do works and is the best we can do for our patients now and in the future. Research is the tool that allows the NHS to do this and Cardiff is committed to contributing to the knowledge pool through research, so that better treatments will be developed for kidney patients nationally and internationally.
It is possible that if you are receiving treatment in the Nephrology & Transplant Directorate at UHW that you will be asked to participate in research. However, it is your right to decline to participate at any time in a project, even half way through. This will not affect your treatment in any way. If you are approached, however, we do hope that you will give sympathetic consideration to taking part.
•The Institute of Nephrology
The Nephrology & Transplant Directorate is closely associated with the Institute of Nephrology, a part of the University of Wales College of Medicine, i.e. the medical school in Cardiff. The Institute is engaged in kidney research and has an international reputation for its work. The medical staff of the Directorate are involved in research and this is usually performed in association with the Institute. The Honorary Director of the Institute is Professor John D. Williams, one of the consultants in the Directorate.
Cardiff is a recognised centre of excellence in terms of medical and scientific research, highlighted by a recent National Research & Development Exercise. There are many nephrology research projects in progress, some laboratory based but others directly involving patient participation. The studies are led by Professor John Williams, Professor Gerald Coles, Dr. Richard Moore, Dr. Nicholas Topley & Mr. Adam Jurewicz. The projects fall into 3 main categories:
Each project has a nurse responsible for running the project.
The following will give you a brief overview of the current studies:
1.Amino Acids Trial (Nutrineal)
This study involves the recruitment of patients new to peritoneal dialysis. The aim of the study is to assess the effectiveness of Nutrineal in preventing malnutrition over a 1 year period. Patients, once consented, are randomised to 2 groups. Group 1 (control group) remain on Dianeal pd4 and Group 2 (experimental group) perform 1 exchange with a Nutrineal pd bag per day. Various measures are taken throughout the study including haematology, U’s & E’s; lipid profile; anthropometry measures and PET’s and adequacy measurements. Further, there is a Quality of Life (QOL) component to this study utilising the Kidney Disease and Quality of Life Questionnaire. QOL is assessed at three time intervals: within weeks 4 to 6; 3 months and at 12 months.
The trial is a multicentre study and Cardiff is the 2nd largest recruiter with 17 patients currently enrolled.
Caszi Green is operationalising this trial.
1.Bicarbonate/Lactate Pd Fluid Study
The aim of this study is to evaluate the safety and efficacy of a Bicarb/lactate bag compared to that of a Dianeal Pd 4 . The study also incorporated a biocompatibility parameter. This longitudinal study will finish in December 199 and the product is expected to be licensed shortly. Currently 2 patients are being followed up.
Rachel Stead is operationalising this trial.
The aim of this study is to determine the effect of peritonitis episodes on the peritoneal membrane. The study commenced in February 1998. This study involves close liaison with the CAPD at UHW in terms of notification of episodes of peritonitis and storage of the incriminating PD effluent. The study involves the collection of the presenting PD effluent bag, collection of the 1st PD effluent bag on day 2 and either day 4 or 5. A bag is also collected at 3 monthly intervals to explore and potential changes in peritoneal function / macrophage activity.
Rachel Stead and Caszi Green are responsible for this trial. 1.Peritoneal Biopsy Registry
This study involves the collection of a specimen (1cm x 1cm) of the peritoneum membrane from patients undergoing abdominal surgery. Peritoneal tissue from 3 groups of patients will be studied:
Group 1: Patients with normal renal function
Group 2: Patients with chronic renal failure not yet receiving renal replacement therapy
Group 3: Patients with ESRD, receiving either haemodialysis or peritoneal dialysis
The study objective is to classify peritoneal tissue and to explore the significance of exposure to dialysate over time. The study is multicentre in nature, participating centres include the UK; France; Japan and the USA. Cardiff is the Principle Investigator.
Kate Craig is operationalising this study.
EPO is a well established treatment for anaemia in ESRD. However, recent therapeutic research developments are recognising NESP (Novel Erythropoietin Stimulating Protein) as a treatment which may rival the EPO market. NESP is very similar to EPO in that it acts in exactly the same way, but the potential advantages of NESP are that the injection may only need to be given once every one or two weeks and lower doses may be just as effective. Currently in Cardiff there is a Phase 11 and Phase 111 NESP study.
Explores efficacy according to dosing schedule. The aim is to identify a dose which will maintain Haemoglobin on a once weekly basis. Obviously this will have implications for patients who currently receive EPO on either a twice or thrice weekly basis.
This phase involves patients already established and stable on EPO. Patients are randomised to either remain on EPO (control group) or to change to NESP. The objective of this study is to compare EPO and NESP in terms of effectiveness and efficacy.
Both Phase 11 and 111 are multicentre and international in nature. There are currently 3 patients involved in Phase 11 and 7 in Phase 111.
Ann Richards is responsible for Phase 11 and 111 and Rachel Stead is responsible for Phase 111 also.
1.Quality of Life (Pilot Study)
The objective of this study is to assess how feasible and how useful it is to measure quality of life in patients with ESRD as part of routine clinical practice. The Renal Quality of Life Profile, developed in Cardiff by Sam Salek (1996) is a self-complete measure specific to ESRD patients, but it is not treatment modality specific. Hence, the tool can be utilised on a cross-section of the ESRD patient population.
The aim is to recruit 300 patients (30 from each of the 10 participating centres). This convenience sample will comprise the pre-dialysis; home haemodialysis; satellite haemodialysis; hospital haemodialysis; CAPD and transplant patient population groups. It is hoped to commence this study in July, 1998.
Jean Jenkins is operationalising this study.
There are many studies occurring within the field of transplantation, mainly because Cardiff has a reputable and well renowned transplant service. Because of the number of studies and the diverse approach required for each study, a second research nurse has been appointed.
1. The Cardiff Study (RES 112)
This is a prospective study investigating the immunological and non-immunological risk factors responsible for transplant rejection/failure. The study is extremely patient intensive in terms of patient follow-up and investigations, particularly cardiac and bone density investigations. Patients are closely followed for a 5 year period. Currently there are 68 patients enrolled on this study.
Gareth Morris-Stiff; Geraldine Hughes and Yvette Webley are responsible for the operationalisation of this study.
2. NEO-INT-05 (RES 214)
This is a multicentre study comparing the efficacy and safety of 3 immunosuppressive regimens (combination of mycophenolate and or azathioprine) given in addition to Neoral for the prevention of acute rejection in kidney transplant patients. Patients are followed up at clinic.
Yvette Webley is operationalising this study.
This is a recent trial investigation of the functional and structural changes in renal transplants following conversion from Neoral to Tacrolimus therapy in patients with proven chronic graft nephropathy. Currently there are 16 patients enrolled on this study and investigations centre around biopsy results and concomitant therapy changes.
Yvette Webley is responsible for operationalising this study. 1.ALERT (Assessment of Lescol in Renal Transplantation)
This is a European multicentre randomised study of the long term effects of Fluvistatin (LESCOL) on major adverse cardiac events and progression of chronic transplant dysfunction in renal transplanted patients. Follow-up is now on a 6 monthly basis and patients have a physical examination, ECG, 24 hour urinalysis and blood analysis. 50 patients were enrolled on this study.
Yvette Webley is responsible for this study.
1.SDZ CHI 621 Study
A multicentre study for the prevention of acute cellular rejection in transplant recipients. The purpose of this study is to investigate the effectiveness of SDZ therapy in preventing/reducing the rate/severity of acute rejection episodes and patients are followed up for a period of 5 years post transplantation. Twenty patients were enrolled to this study and Yvette is responsible for patient follow-up. 1.SOLAR (Study of Lescol in Acute Rejection)
A European multicentre study of the short term effects of Fluvistatin on acute rejection episodes in kidney transplant recipients. The study has 2 objectives:
•to compare the short term effects of treatment with 40mg of Fluvistatin versus a placebo on first treated clinically suspected rejection episodes.
•to investigate the incidence of steroid resistant rejection episodes.
Yvette Webley is responsible for the operationalising of this study.