IMPORTANCE Systematic differences between patients included in randomized clinical trials (RCTs) and the general patient population may influence the generalizability of RCT findings. Comprehensive national registries of patients with end-stage kidney disease who are undergoing dialysis provide a unique opportunity to compare trial and real-world patient cohorts. OBJECTIVE To determine if participants in large, multicenter dialysis trials were similar to the general population undergoing dialysis in terms of age, comorbidities, and mortality rate.
BackgroundThe number of dialysis recipients is growing worldwide, making it important that the full range of patient populations are represented in randomised trials. As trial recruitment has not previously been examined at a global level, we compared the location of trial sites recruiting to large multicentre randomised controlled trials (RCTs) in dialysis to the global distribution of dialysis recipients.MethodsA systematic review (2007–2016) was conducted to identify RCTs enrolling ≥100 dialysis patients from ≥2 sites. The number and location of sites were extracted from manuscripts and trial registration. The proportion of sites from each International Society of Nephrology global region was divided by the proportion of the global dialysis population in that region to determine a ‘representation index’ (RI), where 1.0 indicated that the number of sites was proportionate to the number of dialysis recipients in that region.ResultsWe identified 180 RCTs, recruiting from 6172 sites in 54 countries. Eastern and Central Europe had the highest RI at 2.45. Other well-represented regions were Western Europe (2.20), North America (2.06), and Russia and newly independent states (1.36). Africa had the lowest RI at 0.05, followed by South Asia (0.08), Latin America (0.15), Middle East (0.27), North-East Asia (0.41), and South-East Asia and Oceania (0.62).ConclusionsRegions of the world with growing numbers of dialysis patients are poorly represented in large, multicentre RCTs. Efforts to boost trial participation in these regions are required to ensure that generalisable and relevant information is available to local healthcare providers.
Primary hyperoxaluria (PH) refers to a group of rare autosomal recessive disorders that result in overproduction of oxalate, primarily by the liver. Primary hyperoxaluria type 1 (PH1) is the most common and severe form. 1 Supportive measures may slow the progression of kidney disease, but many patients progress to end stage kidney disease (ESKD). 2 Combined liver-kidney transplantation (CLK) is the treatment of choice; however, outcomes are inferior when transplants are performed later in disease course, with higher total body burden of oxalosis. 3 A 65 year old male developed ESKD in 1998 and underwent deceased-donor kidney transplantation in 2011. The graft failed within 1 year and he was subsequently diagnosed with PH1. Genetic analysis identified two heterozygote pyridoxine-sensitive mutations in the AGXT gene. The patient returned to haemodialysis for 5 years then presented to our unit for CLK. Aiming to prevent early disease recurrence, continuous renal replacement therapy (CRRT) was performed during surgery, followed by daily CRRT for 9 days, then daily intermittent haemodialysis for a further week. Liver allograft function was achieved, however the kidney experienced delayed graft function. Renal biopsy showed acute tubular necrosis and after a further week of dialysis, spontaneous kidney function was evident, and dialysis ceased. On day 29, creatinine was 202 μmol/L and a renal biopsy revealed focal oxalate crystal deposition in 10% of the sample. Repeat biopsy at day 39 showed progressive oxalate deposition. Daily haemodialysis was reinstituted; pyridoxine was administered due to poor oral intake and malnutrition during hospitalization and tacrolimus targets were reduced to 5-8 ng/mL. He was slowly weaned off dialysis at day 65. One year later, he maintains graft function with a creatinine of 300 μmol/L.Evidence surrounding transplantation for PH are limited to small case series and registry data. A retrospective study of 33 CLK recipients showed no recurrence of hyperoxaluria, although those patients were younger, had a much shorter pre-transplant dialysis time and perioperative treatment regimens were not standardized. 4 Patients who are dialysisdependent for several years may have a systemic burden of oxalate, 5 which can persist for several months following CLK despite restoration of oxalate metabolism by the transplanted liver. Estimating total body oxalate burden is extremely difficult and imprecise. Strategies to reduce the oxalate burden are difficult, including low-oxalate diet, low-oxalate Total Parenteral Nutrition (TPN) and intensive dialysis, and must be empirically applied. Awareness of risk of recurrence is critical. A method to measure oxalate burden is urgently required.A 41-year-old man presented with an acute kidney injury, creatinine 685 μmol/L, on a background of diet-controlled type two diabetes mellitus. Renal function 6 months prior was normal, creatinine 90 μmol/L. There was no history of recent illness or dehydration and no symptoms or family history of autoimmune disease. He...
Conclusions: In conclusion, 3H, the largest paediatric dialysis study to date, has shown that HDF improves blood pressure and hemodynamic stability and increases the removal of middle-molecular weight uremic toxins that may, in turn, may halt the progression of vascular disease, improve growth rates and patient related outcome measures compared to conventional HD. Randomised trials to study to confirm these outcomes are required.
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