Mineral metabolism disorders, vertebral fractures and aortic calcifications in stable kidney transplant recipients: The role of gender (EMITRAL study) / Alteraciones del metabolismo mineral, fracturas vertebrales, y calcificaciones aórticas en receptores estables de trasplante renal: papel del género (estudio EMITRAL)

Antecedentes y objetivos: La relación entre las alteraciones del metabolismo mineral, las fracturas óseas y las calcificaciones vasculares en receptores de un trasplante renal no han sido establecidas. Método: Realizamos un estudio transversal en 727 receptores estables procedentes de 28 centros de trasplante españoles. Se determinaron de manera centralizada los parámetros del metabolismo mineral; también se centralizó la semicuantificación de las fracturas vertebrales y de las calcificaciones de la aorta abdominal. Resultados: La deficiencia de vitamina D (25OHD3 < 15ng/ml) fue más frecuente en mujeres y en los estadios CKD-T I-III (29,6 vs. 44,4%; p=0,003). La relación inversa y significativa observada entre los niveles de 25OHD3 y PTH fue modificada por el género de tal manera que la pendiente fue mayor en las mujeres que en los hombres (p=0,01). Un 15% de los receptores mostró alguna fractura vertebral (VFx) con un grado de deformidad ≥2. Los factores relacionados con la VFx diferían en función del género: en los hombres, la edad (OR: 1,04; IC 95%: 1,01-1,06) y el tratamiento con CsA (OR: 3,2; IC 95: 1,6-6,3); en las mujeres la edad (OR: 1,07; IC 95%: 1,03-1,12) y los niveles de PTH (OR per 100pg/ml increase: 1,27; IC 95%: 1,043-1,542). Las calcificaciones de la aorta abdominal fueron comunes (67,2%) y se relacionaron con los factores de riesgo clásicos, pero no con los parámetros del metabolismo mineral. Conclusiones: La deficiencia de vitamina D es más frecuente en las mujeres receptoras de un trasplante renal y en los estadios más tempranos de la CKD-T, y es un factor que contribuye al desarrollo de hiperparatiroidismo secundario. Las VFx prevalentes están relacionadas con unos niveles más elevados de PTH solamente en las mujeres (AU)

Background and objectives: The relationship between mineral metabolism disorders, bone fractures and vascular calcifications in kidney transplant recipients has not been established. Method: We performed a cross-sectional study in 727 stable recipients from 28 Spanish transplant clinics. Mineral metabolism parameters, the semi-quantification of vertebral fractures and abdominal aortic calcifications were determined centrally. Results: Vitamin D deficiency (25OHD3 < 15 ng/ml) was more common in female recipients at CKD-T stages I–III (29.6% vs 44.4%; p=0.003). The inverse and significant correlation between 25OHD3 and PTH was gender-specific and women exhibited a steeper slope than men (p=0.01). Vertebral fractures (VFx) with deformity grade ≥2 were observed in 15% of recipients. Factors related to VFx differed by gender; in males, age (OR 1.04; 95% CI 1.01-1.06) and CsA treatment (OR: 3.2; 95% CI: 1.6-6.3); in females, age (OR 1.07; 95% CI: 1.03-1.12) and PTH levels (OR per 100 pg/ml increase: 1.27; 95% CI: 1.043-1.542). Abdominal aortic calcifications were common (67.2%) and related to classical risk factors but not to mineral metabolism parameters. Conclusions: Vitamin D deficiency is more common among female kidney transplant recipients at earlier CKD-T stages, and it contributes to secondary hyperparathyroidism. Prevalent vertebral fractures are only related to high serum PTH levels in female recipients (AU)

Mineral metabolism disorders, vertebral fractures and aortic calcifications in stable kidney transplant recipients: The role of gender (EMITRAL study).

BACKGROUND AND OBJECTIVES: The relationship between mineral metabolism disorders, bone fractures and vascular calcifications in kidney transplant recipients has not been established. METHOD: We performed a cross-sectional study in 727 stable recipients from 28 Spanish transplant clinics. Mineral metabolism parameters, the semi-quantification of vertebral fractures and abdominal aortic calcifications were determined centrally. RESULTS: Vitamin D deficiency (25OHD3<15ng/ml) was more common in female recipients at CKD-T stages I-III (29.6% vs 44.4%; p=0.003). The inverse and significant correlation between 25OHD3 and PTH was gender-specific and women exhibited a steeper slope than men (p=0.01). Vertebral fractures (VFx) with deformity grade ≥2 were observed in 15% of recipients. Factors related to VFx differed by gender; in males, age (OR 1.04; 95% CI 1.01-1.06) and CsA treatment (OR: 3.2; 95% CI: 1.6-6.3); in females, age (OR 1.07; 95% CI: 1.03-1.12) and PTH levels (OR per 100pg/ml increase: 1.27; 95% CI: 1.043-1.542). Abdominal aortic calcifications were common (67.2%) and related to classical risk factors but not to mineral metabolism parameters. CONCLUSIONS: Vitamin D deficiency is more common among female kidney transplant recipients at earlier CKD-T stages, and it contributes to secondary hyperparathyroidism. Prevalent vertebral fractures are only related to high serum PTH levels in female recipients.

Gastrointestinal quality of life improvement of renal transplant recipients converted from mycophenolate mofetil to enteric-coated mycophenolate sodium drugs or agents: mycophenolate mofetil and enteric-coated mycophenolate sodium.

BACKGROUND: In renal transplant (RT) recipients, treatment with enteric-coated mycophenolate sodium (EC-MPS) improves gastrointestinal (GI) tolerability compared with mycophenolate mofetil (MMF). The impact of conversion from MMF to EC-MPS on patient's health-related quality of life (HRQoL) using GI-specific instruments has been scarcely evaluated in randomized trials. METHODS: The present randomized, multicenter, open-labeled, 12-week study included RT recipients experiencing GI adverse events due to MMF treatment. Patients were randomized to continue with MMF (n=54) or change to EC-MPS (n=59). Patients were converted at equimolar doses, and dose was optimized between weeks 2 and 6 to achieve maximum tolerated dose. RESULTS: Incidence of GI complications (particularly diarrhea) was significantly lower in the EC-MPS group (67.8% vs. 87.0%, P=0.015). The baseline-adjusted mean global scores at 12 weeks in GI quality of life index were significantly higher in the EC-MPS group versus MMF (P=0.014). Results at 12 weeks for all secondary scales indicated better HRQoL in the EC-MPS group compared with the MMF group (Gastrointestinal Symptom Rating Scale, Psychological General Well-Being Index, and overall treatment effect). In the EC-MPS group, a higher percentage of patients were receiving intermediate doses of mycophenolic acid (720 mg/day) at 12 weeks compared with MMF (55.4% vs. 27.4%, P=0.003), whereas no differences were observed for high doses (>720 mg/day). CONCLUSIONS: In RT patients with GI undesirable effects due to MMF, switching from MMF to EC-MPS may enable an increase in the maximum tolerated dose of mycophenolic acid and reduce GI complications, thus enhancing patients' GI HRQoL.

[Present situaltion of living-donor kidney transplantation in Spain and other countries: past, present and future of an excellent therapeutic option]. / Situación actual del trasplante renal de donante vivo en España y otros países: pasado, presente y futuro de una excelente opción terapéutica.

Kidney transplantation from living donor is an established treatment in Spain since the 60s but has maintained a low level of activity until 2000, when the number of procedures and hospitals that perform this therapy experienced a gradual increase, reaching the highest figure in our history in 2009, with 235 living donor kidney transplants (which represents 10% of renal transplant activity). The reasons why living donor kidney transplantation is emerging in our country are diverse and can be focused in four main areas. 1) Better outcomes obtained when using living donors for kidney transplantation than those obtained with kidneys from deceased donors. Younger recipients with better HLA matching, the good health of the donor, the absence of any damages that occur in the kidney secondary to brain death, the small ischemic time and the possibility of preemptive transplantation can explain the best graft and patient survival. 2) The scarcity of sources: the relaxation of entry criteria on the waiting list implies an increasing challenge of the demand for transplant without the contribution of living donor kidney transplantation, especially in young recipients where the chances of obtaining an age-appropriate deceased donor are lower, due to the change in the profile of the deceased donor (increasingly older). 3) Improvement in the safety of the donor: the excellent evaluation and monitoring of donors (based on international standards) plus the use of less invasive surgical techniques are related to a low complication rate and to survival expectancies of living donors being similar to those of the general population. 4) Barriers overcome: The training effort by the transplant teams, hospital and regional coordinations, and the National Transplant Organization is giving excellent results, visible in the gradual increase in the number of hospitals with a program of living donor kidney transplantation and its activity. In addition, desensitization programs and the national cross-over kidney transplantation program have removed barriers to transplantation in cases of ABO incompatibility or positive crossmatch.

Objetivos y metodología de las Recomendaciones de la SEN-ONT sobre trasplante renal de donante vivo / Objectives and methodology of SEN-ONT recommendations for living-donor kidney transplantation

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Situación actual del trasplante renal de donante vivo en España y otros países: pasado, presente y futuro de una excelente opción terapéutica / Present situation of living-donor kidney transplantation in Spain and other countries: past, present and future of an excellent therapeutic option

El trasplante renal de donante vivo es un tratamiento establecido en España desde los años sesenta, pero ha mantenido unos escasos niveles de actividad hasta el año 2000, fecha en que comienza un incremento progresivo en el número de procedimientos y de hospitales que realizan esta terapia, alcanzando en el año 2009 la cifra más alta de nuestra historia, con 235 trasplantes renales de donante vivo (que suponen un 10% de la actividad de trasplante renal). Los motivos por los que el trasplante renal de donante vivo está emergiendo en nuestro país son diversos y pueden englobarse en cuatro grandes apartados: 1) M ejores resultados que el trasplante renal de donante fallecido. Receptores más jóvenes con una mejor compatibilidad HLA, el buen estado de salud del donante, la ausencia de los posibles daños que se producen en el riñón secundariamente a la muerte encefálica, el menor tiempo de isquemia y la posibilidad de realizar el trasplante anticipado explican la mejor supervivencia de injerto y de paciente. 2) Necesidad de trasplante de vivo: la flexibilización de criterios de entrada en lista de espera conlleva una mayor dificultad de atender a la demanda de trasplante sin ayuda del trasplante renal de donante vivo, sobre todo en receptores jóvenes en los que las posibilidades de obtener un órgano adecuado a su edad son menores, debido al cambio en el perfil de los donantes fallecidos (cada vez de mayor edad). 3) M ejora en la seguridad del donante: la excelente evaluación y seguimiento de los donantes (basada en estándares internacionales), además de la utilización de técnicas quirúrgicas menos invasivas, conlleva un bajo índice de complicaciones y una esperanza de vida de los donantes similar a la de la población general. 4) Obstáculos superados: el esfuerzo en formación realizado por los equipos de trasplante, coordinaciones hospitalarias, autonómicas y la Organización Nacional de Trasplantes (ONT) está dando excelentes resultados, visibles en el progresivo aumento en el número de hospitales con programa de trasplante renal de donante vivo y en su actividad. Por otra parte, los programas de desensibilización y el programa nacional de donación renal cruzada han eliminado las barreras al trasplante en los casos de incompatibilidad ABO o prueba cruzada positiva (AU)

Kidney transplantation from living donor is an established treatment in Spain since the 60s but has maintained a low level of activity until 2000, when the number of procedures and hospit als t hat perf orm t his t herapy experienced a gradual increase, reaching the highest figure in our history in 2009, with 235 living donor kidney transplants (which represents 10% of renal transplant activity). The reasons why living donor kidney transplantation is emerging in our country are diverse and can be focused in four main areas. 1) Better outcomes obtained when using living donors for kidney transplantation than those obtained with kidneys from deceased donors. Younger recipients with better HLA matching, the good health of the donor, the absence of any damages that occur in the kidney secondary to brain death, the small ischemic time and the possibility of preemptive transplantation can explain the best graft and patient survival. 2) The scarcity of sources: the relaxation of entry criteria on the waiting list implies an increasing challenge of the demand for transplant without the contribution of living donor kidney transplantation, especially in young recipients where the chances of obtaining an age-appropriate deceased donor are lower, due to the change in the profile of the deceased donor (increasingly older). 3) Improvement in the safety of the donor: the excellent evaluation and monitoring of donors (based on international standards) plus the use of less invasive surgical techniques are related to a low complication rate and to survival expectancies of living donors being similar to those of the general population. 4) Barriers overcome: the training effort by the transplant teams, hospital and regional coordinations, and the National Transplant Organization is giving excellent results, visible in the gradual increase in the number of hospitals with a program of living donor kidney transplantation and its activity. In addition, desensitization programs and the national cross-over kidney transplantation program have removed barriers to transplantation in cases of ABO incompatibility or positive crossmatch (AU)