Evaluation of a biosimilar recombinant alpha epoetin in the management of anemia in hemodialysis patients.

BACKGROUND: The efficacy of human recombinant erythropoietins (rHuEPOs) in the treatment of anemia with different etiologies is proven. Development of biosimilar rHuEPO products with lower cost and wider availability is important for the care of anemic patients. OBJECTIVE: The aim of the present study was to determine the bioequivalence and safety of a biosimilar rHuEPO (Pastopoitin(®)) and compare it with the innovator product Eprex(®), as a standard rHuEPO. METHODS: One hundred and seven anemic patients on stable hemodialysis were recruited to this randomized double-blind comparative trial and assigned to either subcutaneous Pastopoitin (n = 50) or Eprex (n = 57). Each study group received rHuEPO at a dose of 80-120 IU/kg/week in 2-3 divided doses for a period of 3 months. Hematologic parameters including Hemoglobin, hematocrit, RBC, EBC, platelet, MCV, MCH and MCHC were checked every 2 weeks. Blood iron, ferritin, TIBC, creatinine, BUN and electrolytes (Na, K, Ca and P) were evaluated monthly over the 3 months. RESULTS: A significant increase in hemoglobin, hematocrit and RBC was observed by the end of study in both Pastopoitin and Eprex groups (p < 0.001). However, these factors were not significantly different between the groups, neither at baseline nor at the end of study (p > 0.05). Likewise, the groups were comparable regarding MCV, MCH, MCHC, iron, ferritin, TIBC, creatinine, BUN and electrolytes at baseline as well as at the end of trial. Adverse events were not serious and occurred with the same frequency in the study groups. CONCLUSION: Pastopoitin showed comparable efficacy and safety profile with Eprex in anemic patients on hemodialysis. Hence, Pastopoitin may be considered as a rHuEPO with a lower cost and wider availability compared with the innovator product Eprex.

Are Doppler ultrasonography parameters symmetric between the right and left kidney?

BACKGROUND: Among numerous modalities applied for evaluation of kidney diseases, Doppler ultrasonography (DU) provides information about the hemodynamic status of the kidneys. Meanwhile, the variability in DU parameters of the right and left kidney is a matter of controversy. The aim of this study was to determine whether any difference exists between the DU indices of the right and left kidney. METHODS: Retrospectively, we collected DU findings of 25 healthy potential renal transplant donors. All donors underwent renal DU and multidetector computed tomographic angiography before donor nephrectomy. DU indices, including peak systolic volume (PSV), resistive index (RI), pulsatility index (PI), end-diastolic volume (EDV), and acceleration time (AT), were recorded. RESULTS: The median age of the donors was 27 (range 23-39) years. The median PSV, RI, EDV, and AT for the right kidney were 29 cm/sec, 0.59, 10.9 cm/sec, and 50 msec, respectively. For the left kidney, the median PSV, RI, EDV, and AT were, respectively, 26.8 cm/sec, 0.60, 10.6 cm/sec, and 43 msec. Among the DU indices, median PI of the right kidney was significantly different from that of the left kidney (1.02 versus 0.95, P = 0.01). CONCLUSION: In conclusion, the present study revealed that right kidney DU indices, except for PI, may not differ from those of the left kidney.

Brucellosis mimicking vasculitis in a patient with renal failure and peripheral neuropathy.

Very few reports of brucellosis with overt renal failure exist in the literature. The authors report interstitial nephritis and distal sensory-motor polyneuropathy as the presenting features of brucellosis. It is postulated that immunologic hypersensitivity reactions may play a role in the pathogenesis of brucellosis. A brief review on this topic is presented.

Peri-hilar branching patterns and morphologies of the renal artery: a review and anatomical study.

The peri-hilar (extra-parenchymal) branching pattern of the renal artery is important for surgeons to know prior to kidney transplantation. The aim of this study was to identify the variations in peri-hilar branching pattern and morphology of the main renal artery. Arteriograms of 81 kidneys were examined. After marking the renal shadow, the main renal artery was traced laterally from its origin. Morphologically, the arterial branching patterns were classified into ladder (with sequential branching points) and fork (with a common branching point) types. The latter was either duplicated or triplicated. The peri-hilar morphology of the main renal artery was then categorized according to its primary and secondary divisions and their patterns. If a single category encompassed at least 5% of the observed figures, it was recorded as a "cardinal" peri-hilar arterial morphology. Otherwise, it was counted within the category of "infrequent" morphologies. At the level of the main artery, a fork pattern was observed in 92.6% (n = 75) (80.2% duplicated (n = 65) and 12.4% triplicated (n = 10)) and a ladder pattern in 7.4% (n = 6) of kidneys. Of 160 primary branches off the fork-type main artery, a secondary division was found in 68.8%. Only one further division (4.4%) was noted from the ladder-type primary arteries. Eight "cardinal" peri-hilar renal arterial morphologies were identified and represented 82.7% of all cases. At least ten "infrequent" morphologies were also found. These patterns showed some alteration with the presence of a supernumerary renal artery. We concluded that the peri-hilar branching of main renal artery is highly variable, though this may follow certain patterns. We believe that the results may be useful to surgeons operating at the renal hilum especially during kidney transplantation.

Thrombotic microangiopathy in the early post-renal transplant period.

The aim of this study was to identify cases of post-renal transplant thrombotic microangiopathy in a single transplant center over a period of five years. In a retrospective study, we reviewed the renal biopsy specimens of 57 renal transplant recipients with allograft dysfunction. The presence of fibrin thrombi within the glomerular capillaries or arterioles was used to define thrombotic microangiopathy. Systemic thrombotic microangiopathy was justified with the presence of thrombocytopenia and evidence of microangiopathic hemolysis. Patients with the biopsy findings compatible with thrombotic microangiopathy but without any systemic findings were categorized as having localized thrombotic microangiopathy. Four out of 57 patients had systemic thrombotic microangiopathy, while two had localized disease. The characteristics of each patient are discussed. Post-transplant thrombotic microangiopathy constitutes 10.5% of cases of early renal allograft dysfunction. A high index of suspicion is needed for diagnosing this entity as a potential cause of post-kidney transplant allograft dysfunction. Further studies with a greater number of patients may be required to highlight the risk factors for post-renal transplant thrombotic microangiopathy.

Calcium and phosphorus metabolism in stable renal transplant recipients.

OBJECTIVES: This study sought to elucidate the status of calcium, phosphorus, and parathyroid hormone in patients following kidney transplant. MATERIALS AND METHODS: In this cross-sectional study, 20 renal transplant recipients were evaluated. For each patient, age, sex, time since transplant, and body weight were recorded. Inclusion criteria were age > 14 years and good allograft function defined as a serum creatinine level < 132.6 micromol/L for at least 6 months after transplant. Exclusion criteria were immunosuppressive therapy other than the standard triple regimen (cyclosporine, prednisolone, and mycophenolate mofetil or azathioprine) and use of any drug known to alter calcium hemostasis. Levels of 24-hour urine calcium, phosphorus, creatinine, and uric acid, as well as concentrations of hemoglobin, serum creatinine, calcium, and phosphorus were measured. To obtain a mean value of serum intact parathyroid hormone in transplant recipients at our center, serum intact parathyroid hormone levels were additionally quantitated in another group of 30 renal transplant recipients. RESULTS: The mean hemoglobin level was 135.6 +/- 17.7 g/L, the mean serum creatinine level was 105.0 +/- 15.3 micromol/L, and the mean serum calcium and phosphorus levels were 2.25 +/- 0.17 mmol/L (normal range, 2.02-2.60 mmol/L) and 1.28 +/- 0.24 mmol/L (normal range, 0.81-1.61 mmol/L), respectively. The mean serum intact parathyroid hormone level was 33.17 +/- 14.67 ng/L (normal range, 10-60 ng/L). Mean 24-hour urine calcium and phosphorus values were 2.32 +/- 1.68 mmol/day (normal, 2.49-6.24 mmol/day) and 19.77 +/- 8.31 mmol/day (normal, 12.91-41.98 mmol/day), respectively. A positive correlation was found between serum calcium and alkaline phosphatase levels (r = +0.71, P = .006). Hemoglobin level was negatively correlated with serum phosphorus level (r = -0.65, P = .003) and sex (r = -0.57, P = .003) and positively correlated with urine creatinine levels (r = +0.69, P = .001). CONCLUSIONS: Renal transplant recipients with stable allograft function may have normal serum calcium, phosphorus, and intact parathyroid hormone levels. However, presence of hypocalciuria and elevated serum alkaline phosphatase levels might imply impaired calcium metabolism in these patients.

Comparison of glucose tolerance in renal transplant recipients and hemodialysis patients.

BACKGROUND: Impaired glucose tolerance is a risk factor for atherosclerosis in hemodialysis patients and renal transplant recipients. METHODS: To check the relationship of impaired glucose tolerance with the other atherosclerotic risk factors, fasting blood sugar and the standard two hour glucose tolerance test, serum tryglyceride, serum cholesterol, cyclosporine through level (in renal transplant recipients) and hemoglobin A1C were measured in 55 stable renal transplant recipients, 55 hemodialysis patients and 55 healthy controls with similar demographic characteristics. Patients with diabetes mellitus and propranolol consumers were excluded. The mean age and female to male ratio were 39 +/- 7 years and 23/22, respectively. RESULTS: Four of the renal transplant recipients and twelve of the hemodialysis patients had impaired glucose tolerance. Significant linear correlation was observed with body mass index and IGT only in hemodialysis patients (r = 0.4, p = 0.05). Glucose tolerance also had a significant correlation with triglyceride levels (217.2 +/- 55 mg/dl in hemodialysis patients vs. 214.3 +/- 13 mg/dl in renal transplant recipients and 100.2 +/- 18 mg/dl in control groups, p = 0.001). The glucose tolerance had significant relationship with higher serum cholesterol levels only in the renal transplant recipients (269.7 +/- 54 in renal transplant recipients vs. 199.2 +/- 36.6 mg/dl in hemodialysis and 190.5 +/- 34 mg/dl in control groups, p = 0.0001). In the renal transplant recipients, a linear correlation was observed with glucose tolerance and both the serum cyclosporine level (r = 0.9, p = 0.001) and the hemoglobin A1C concentration (6.2 +/- 0.9 g/dl). The later correlation was also observed in the hemodialysis patients (6.4 +/- 0.7 g/dl; r = 67, p = 0.001). CONCLUSIONS: We conclude that although fasting blood sugar is normal in non-diabetic renal transplant and hemodialysis patients, impaired glucose tolerance could be associated with the other atherosclerotic risk factors.