Reproductive function in female patients (pts) with advanced kidney disease is decreased and characterised by diminished libido, ovulation and infertility. The underlying cause is hypothalamic-hypophysis-gonadal axis dysfunction in women with chronic kidney disease which usually results in high levels of prolactin and.ammenorrhea In women with end stage kidney disease requiring replacement therapy in fertile period conception is very rare. Even in case of conception successful pregnancy and delivery are not likely, on most occasions spontaneous abortion occurs. Should a newly pregnant woman on haemodialysis wish to deliver the baby, intensive dialysis is required, everyday until childbirth. In the haemodialysis center in University Clinical Center in Ljubljana, only one woman in the chronic dialysis programme gave birth, in 1996.

In this prospective, randomized, open-label, single-center study, we compared the efficacy and safety of two anti-interleukin-2 receptor monoclonal antibodies among adult recipients of at least 1 HLA-mismatched deceased donor renal grafts. Eligible patients were randomized to induction with either basiliximab or daclizumab. Both groups received cyclosporine microemulsion (CsA Neoral), mycophenolate mofetil, and methylprednisolone. An intent-to-treat analysis of 1-year data assessed the incidence of acute rejection episodes, the renal graft function, the safety, and the patient and graft survivals. Among 127 patients, six (10.0%) and seven (11.5%) patients experienced biopsy-confirmed acute rejection at 12 months, in the basiliximab and the daclizumab groups, respectively. Two renal grafts were lost in the basiliximab and six in the daclizumab cohort, one of them due to rejection. One basiliximab and two daclizumab patients died. Hospital treatment was required for 25 and 33 infections in basiliximab and daclizumab groups, respectively. One basal cell carcinoma of skin was detected. One hypersensitivity reaction was observed with daclizumab. At 12 months, serum creatinine was 101 ± 28 μmol/L with basiliximab and 109 ± 41 μmol/L with daclizumab. Patient survival was 98.4% with basiliximab and 96.7% with daclizumab, and graft survival was 96.8% versus 90.8%, respectively. No significant differences were observed between the groups. Basiliximab or daclizumab combined with triple therapy was an efficient and safe immunosuppression strategy, demonstrated with low incidence of acute rejection episodes, an acceptable adverse event profile, excellent graft function, and high survival rates in adult recipients within the first year after deceased donor renal transplantation.

We studied prospectively the efficacy and safety of basiliximab combined with triple immunosuppression in adult recipients of ≥1 HLA-mismatched deceased donor renal grafts. All studied patients received equal immunosuppressive drugs: 20 mg infusion of basiliximab on day 0 and on day 4, cyclosporine microemulsion (Neoral), mycophenolate mofetil, and methylprednisolone. An analysis of 1-year data assessed the incidence of acute rejection episodes, safety of this therapy, renal graft function, and patient and graft survivals. One hundred seventy-two patients were studied. The HLA-antigen mismatches were 2.9 ± 0.9 (mean ± SD), and the cold ischemia time was 22.0 ± 7.5 hours. Fifty-three (31.5%) patients experienced delayed graft function. At 12 months, 5 (3.0%) patients experienced acute rejection. Six renal grafts were lost, but not from rejection. Two patients died. Sixty-six infections required treatment in the hospital. One carcinoma of cervix (in situ) and two basal cell carcinomas of skin were detected. Hypersensitivity reactions and cytokine-release syndrome were not observed. At 12 months, serum creatinine was significantly higher (119 ± 46 μmol/L; P < .001) in patients with delayed graft function than in patients with immediate graft function (99 ± 26 μmol/L). Patient and graft survivals were 98.8% and 97.1%, respectively. Basiliximab combined with this triple therapy was an efficient and safe immunosuppression strategy, demonstrated with very low incidence of acute rejections, an acceptable adverse event profile, excellent graft function, and high short-term survival rates in adult recipients of deceased donor renal transplant.

Aim The aim of our study was to analyze cyclosporine (Cs)‐related toxic effects that demanded conversion to tacrolimus (Tc), and the influence on blood pressure (BP), glucose control and graft function.Methods From 1989 to 2003 10 patients (15 to 48 years), were treated with Cs from 2 months to 11 years. The Cs dose was adjusted to maintain the target blood trough levels of 100–170 µg/mL during first three post‐transplant months and 70–100 µg/mL afterwards. Patients were switched to Tc due to following Cs‐related toxic effects: gingival hypertrophy (8), hirsutism (1), hemolytic uremic syndrome (HUS) (3), and tremor (1). The Tc dose was adjusted to maintain a target whole blood trough level of 10–20 ng/mL during the first 3 months after transplantation and 5 to 15 ng/mL afterwards.Results After 3 to 46 months of follow‐up Cs‐related toxic effects (gingival hypertrophy, hirsutism, HUS, tremor) significantly diminished, systolic and diastolic blood pressure were decreased from 142 mmHg to 130 mmHg and from 87 mmHg to 83 mmHg, respectively (P < 0.005 and P = 0.095, respectively), while no significant change was observed in plasma fasting glucose levels. The calculated GFR (Nankivell formula) was 69 mL/min (range 91 to 44 mL/min) 3 to 6 months before conversion and 67 mL/min (range 37 to 101 mL/min) 3 to 6 months after conversion (P = 0.279).Conclusion Our results show that kidney allograft function was stable after conversion from Cs to Tc in the short‐term period. The benefits of conversion from Cs to Tc included significant reduction in Cs‐related toxic effects and also reduction of systolic blood pressure.

Objectives The aim of our study was to: (i) assess the number of patients who need epoetin treatment and the adequacy of iron treatment, (ii) assess the influence of presence of diabetes mellitus, polycystic kidney disease and the influence of therapy with aluminum phosphate binders and angiotensin system antagonists on the epoetin requirements, (iii) assess the role of other factors possibly influencing epoetin resistance – secondary hyperparathyroidism, inflammation, dialysis dose and residual renal function.Design and Methods Fifty‐one stable peritoneal dialysis (PD) patients (mean age ± SD was 52 ± 13 years, 20 women) without recent bleeding, surgery, bone marrow disease, malignancy, or hypothyroidism were recruited in four Slovenian centers. The dose of epoetin was adjusted to maintain a target hemoglobin of above 110 g/L. At the time of inclusion (median 36 months of PD, range 3–124 months) the PET test results and relevant clinical and laboratory parameters were recorded. Index of epoetin resistance (IRE) was expressed as weekly epoetin dose/body weight/hemoglobin concentration.Results Twenty four percent of patients did not need epoetin treatment, the rest were treated with Epoetin‐beta at a dose of 70 ± 56 U/kg/week s.c.; hemoglobin concentration was 124 ± 15 g/L; 14% had hemoglobin below 110 g/L. Iron adequacy parameters (ferritin > 100 µg/L and TSAT > 20%) were fulfilled by 63% of patients, and their IRE was lower (0.43 ± 0.5 U/kg/week/g/L vs. 0.6 ± 0.72 U/kg/week/g/L), but not significantly (P = 0.502). Patients with polycystic kidneys had lower IRE (0.13 ± 0.3 vs. 0.52 ± 0.55 U/kg/week/g/L, P = 0.011) and majority of them (71%) did not need epoetin treatment (P = 0.006). No difference was found for diabetic patients. Treatment with angiotensin system antagonists, but not with aluminum phosphate binders, is associated with increased IRE (0.56 ± 0.59 vs. 0.3 ± 0.4 U/kg/week/g/L, P = 0.038). A statistically significant correlation was found for IRE and CRP (r = 0.48, P = 0.001) and iPTH (r = 0.46, P = 0.001). No correlation between IRE and residual renal function was found (r = −0.2, P = 0.173). Stepwise linear regression analysis for multiple variables (residual renal glomerular filtration rate, total weekly creatinine clearance, CRP, iPTH, iron adequacy, angiotensin system antagonist treatment, presence of polycystic kidneys) showed CRP and treatment with angiotensin system antagonists to be the most significant variables influencing IRE.Conclusion Our results show that systemic inflammation and angiotensin system antagonist treatment are the most important parameters affecting epoetin requirements in stable peritoneal dialysis patients.

The study was based on 462 patients who underwent kidney transplantation from 1986 through 2004. Cyclosporine (CsA)-related thrombotic microangiopathy (TMA) was observed in 15 (3.3%) patients. The donor ages ranged from 9 to 51 years and cold ischemia times from 12 to 31 hours. Hemolytic-uremic syndrome (HUS) developed 2 weeks after transplantation in 14 patients and later in 1 subject. Histopathologic examination demonstrated glomerular-type TMA in 3 patients, a mixed type (glomerular and vascular) in 11 patients, and a nonspecific mesangial widening with tubulointerstitial lesions in 1 patient. Follow-up biopsies revealed resolution of TMA in 4 patients and chronic vascular TMA in 1 patient. Six patients with mixed-type TMA needed transient hemodialysis. No patient with the glomerular-type TMA needed dialysis (P = .103), and 14 of 15 had good resolution of graft function after CsA dose reduction or temporary discontinuation or continuation of optimal dose. Only 1 graft with mixed-type TMA was lost due to irreversible HUS. The mean glomerular filtration rate (GFR), predicted by the Nankivell equation, was 76 +/- 13 mL/min and 80 +/- 27 mL/min at 1 month after discharge for glomerular- and mixed-type TMA, respectively (P > .05). GFRs 1 year after HUS were 82 +/- 12 and 87 +/- 21 mL/min for the glomerular and the mixed types, respectively (P > .05). We concluded that the mixed-type TMA was associated with a more severe early clinical course than the glomerular-type TMA. The 1-year prognosis was good in the majority of patients, with no significant differences between those with the glomerular- and mixed-type TMA.

We assessed the efficacy and safety of basiliximab combined with triple immunosuppression in adult recipients of at least 1 HLA‐mismatched cadaveric renal allograft. All studied patients, transplanted between October 1999 and December 2003, received equal immunosuppression: 20 mg infusion of basiliximab on day 0 and on day 4, infusion of cyclosporine (CyA) (0.08 mg/kg/h) started at operation and continued by CyA‐Neoral, 3 mg/kg b.i.d. on day 2, methylprednisolone, 0.4 mg/kg i.v. at operation, and mycophenolate mofetil started on day 1. CyA‐Neoral dose was adjusted to maintain blood trough levels of 150–250 ng/mL (FPIA, monoclonal). Oral methylprednisolone was tapered by 4 mg per week to achieve a maintenance dose of 0.08 mg/kg/day. A total of 153 patients, with mean age of 46 ± 11 years (SD; range 18–65 years), were studied. Thirteen of them received second renal allograft. The mean donor age was 37 ± 14 years (range 6–61 years). Mean cold ischemia time was 22.0 ± 8.0 h (range 7.0–41.0 h), mean value of HLA‐antigen mismatches was 3.0 ± 0.9 (range 1–5), mean latest PRA value was 8 ± 14% (range 0–85%). 47 patients experienced delayed graft function. During a follow‐up of 3 months no acute rejection episode occurred. Four renal allografts were removed, but not for rejection. One patient died because of sepsis. In one patient life‐threatening CMV disease was successfully treated. One malignancy (skin basal cell carcinoma) was detected. Hypersensitivity reactions and cytokine‐release syndrome were not observed. After 3 months mean serum creatinine was 111 ± 36 µmol/L (range 53–238 µmol/L). Patient and graft survival was 99.3% and 97.4%, respectively. We conclude that basiliximab with this triple therapy is an efficient and safe immunosuppression strategy, demonstrated with absence of early acute rejection episodes, excellent allograft function, acceptable adverse event profile and high short‐term survival rate.

The objective of our study was to assess the influence of residual renal function and other factors on epoetin requirements in chronic peritoneal dialysis patients. Fifty-one stable patients (mean age +/- SD: 52 +/- 13 years; 20 women) without recent bleeding, bone marrow disease or malignancy were recruited in four Slovenian centers. The target hemoglobin was above 110 g/L. The peritoneal equilibration test results and relevant clinical and laboratory parameters were recorded. The epoetin resistance index was expressed as a weekly epoetin dose/body weight/hemoglobin concentration. Twenty-four percent of the patients did not need epoetin treatment, the rest were treated with epoetin-beta in a dose of 70 +/- 56 U/kg per week s.c.; the hemoglobin concentration was 124 +/- 15 g/L. Ferritin > 100 mu g/L and transferrin saturation > 20% fulfilled 63% of patients whose epoetin resistance index was not significantly lower (0.43 +/- 0.5 U/kg per week per g/L vs 0.6 +/- 0.72 U/kg per week per g/L, P = 0.502). No difference was found between diabetic and non-diabetic patients. Treatment with angiotensin system antagonists, but not with aluminum phosphate binders, was associated with increased epoetin resistance index (0.56 +/- 0.59 vs 0.3 +/- 0.4 U/kg per week per g/L, P = 0.038). No correlation between epoetin resistance index and residual glomerular filtration rate was found (r = -0.2, P = 0.173). A multiple linear regression analysis showed C-reactive protein, intact parathormone level, female sex and treatment with angiotensin system antagonists to be the independent predictors influencing epoetin resistance index. Our results show that systemic inflammation, secondary hyperparathyroidism and angiotensin system antagonist treatment are the most important modifiable parameters affecting epoetin requirements in stable peritoneal dialysis patients.