- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01393808
Salt Intake and Antiproteinuric Effect of Paricalcitol in Type 2 Diabetes (PROCEED)
A Prospective, Randomized, Cross-over, Double-blind, Placebo-controlled Study to Assess the Antiproteinuric Effect of Selective Vitamin d Receptor Activation by Paricalcitol in Type 2 Diabetes Patients on Low or High Sodium Diet and Stable Ras Inhibitor Therapy
Proteinuria is an independent risk factor for cardiovascular morbidity and mortality and for renal disease progression. More proteinuria is associated with faster progression, whereas treatments that reduce proteinuria are renoprotective in both diabetic and non diabetic chronic kidney disease. Of note, lower the residual proteinuria achieved by treatment slower is the disease progression in the long term. On the basis of the above findings, proteinuria has become a target of renoprotective therapy.
Among different antihypertensive medications, those that inhibit the Renin Angiotensin System, such as angiotensin converting enzyme (ACE)inhibitors and angiotensin receptor blockers (ARBs), are those that at comparable blood pressure control, more effectively reduce proteinuria and slow renal disease progression. Thus they have become the key component of renoprotective therapy in patients with proteinuric chronic kidney disease. Observational studies found that their effectiveness, however, is limited or even fully blunted in patients who eat large amount of salt.
Experimental evidence indicates a renoprotective role of the vitamin D system in chronic renal disease. A recent randomized, controlled trial, add-on therapy with selective Vitamin D receptor activator paricalcitol showed an additive antiproteinuric effect in subjects with type 2 diabetes and chronic kidney disease on background Renin-angiotensin-system inhibitor therapy. This effect, however, was largely restricted to subjects with daily sodium intake exceeding 12 grams and was negligible in those with lower sodium intake. Thus, treatment with paricalcitol appears to be effective in particular in those patients who do not appreciably benefit of renin angiotensin system (RAS) inhibitors therapy because of high salt intake. Thus, whether the antiproteinuric effect of paricalcitol is modified by concomitant salt intake in patients with chronic kidney disease (CKD) on background RAS inhibitors therapy, is worth investigating.
The broad aim of this study is to evaluate the interaction between paricalcitol therapy and sodium intake in type 2 diabetes patients with proteinuric kidney disease on stable background RAS inhibitor therapy.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Bergamo, Italia
- Azienda Ospedaliera Ospedali Riuniti di Bergamo
-
-
BG
-
Romano di Lombardia, BG, Italia
- Azienda Ospedaliera di Treviglio e Caravaggio - Unit of Diabetology and Metabolic Diseases
-
Seriate, BG, Italia
- Azienda Ospedaliera Bolognini - Unità di Medicina
-
Treviglio, BG, Italia
- Azienda Ospedaliera di Treviglio e Caravaggio - Unit of Diabetology and Metabolic Diseases
-
-
Bergamo
-
Brembate, Bergamo, Italia, 24030
- ASL of Ponte San Pietro - Diabetologic Unit
-
Ranica, Bergamo, Italia, 24020
- Clinical Research Center fo Rare Diseases Aldo and Cele Daccò
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Male and female patients;
- Age > 18 years;
- Type 2 diabetes patients on low or high sodium diet and stable RAS inhibitor therapy with the following conditions:
Urinary albumin excretion (UAE) rate >300mg/24 hours (200 mcg/min); Serum creatinine <2 mg/dL, PTH ≥ 20 mEq/L and <110 mEq/L; Calcium and phosphorus levels < 9.5 mg/dl and < 5mg/dl, respectively; Controlled BP (systolic/diastolic <140/90 mmHg) while on stable RAS inhibitor therapy;
- Written informed consent.
Exclusion Criteria:
- Previous Vitamin D or Vitamin D analogs therapy (within 3 months prior to the study entry);
- Evidence of toxicity to Vitamin D;
- History of kidney stones;
- Poorly controlled Diabetes: Hb1Ac > 12%;
- Therapy with calcitonin, bisphosphonates, cinacalcet, glucocorticoids, immunosuppressive drugs or other drug that may affect calcium or bone metabolism;
- Cancer and any severe systemic disease or clinical condition that may jeopardize data interpretation or completion of the study;
- Any clinically relevant conditions that might affect study participation and/or study results;
- Any contraindication to be exposed to Paricalcitol;
- Pregnancy or lactating;
- Women of childbearing potential without following a scientifically accepted form of contraception;
- Legal incapacity.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador de placebos: placebo
|
1-month Placebo Treatment
|
Experimental: Paricalcitol
|
1-month Paricalcitol 2mcg/day
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Changes in urinary albumin excretion from baseline at 4 month.
Periodo de tiempo: At baseline and 1,2,3 and 4 month.
|
At baseline and 1,2,3 and 4 month.
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Ambulatory and 24-hour blood pressure profile.
Periodo de tiempo: At 1 month.
|
At 1 month.
|
Ambulatory and 24-hour blood pressure profile.
Periodo de tiempo: At 2 month.
|
At 2 month.
|
Ambulatory and 24-hour blood pressure profile.
Periodo de tiempo: At 3 month.
|
At 3 month.
|
Ambulatory and 24-hour blood pressure profile.
Periodo de tiempo: At 4 month.
|
At 4 month.
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Publicaciones Generales
- Prabhu RA, Saraf K. Vitamin D in diabetic nephropathy. J Postgrad Med. 2018 Jan-Mar;64(1):5-6. doi: 10.4103/jpgm.JPGM_311_17. No abstract available.
- Parvanova A, Trillini M, Podesta MA, Iliev IP, Ruggiero B, Abbate M, Perna A, Peraro F, Diadei O, Rubis N, Gaspari F, Carrara F, Stucchi N, Belviso A, Bossi AC, Trevisan R, Remuzzi G, de Borst M, Ruggenenti P; PROCEED Study Organization and the Scientific Writing Academy (SWA) 2016. Moderate salt restriction with or without paricalcitol in type 2 diabetes and losartan-resistant macroalbuminuria (PROCEED): a randomised, double-blind, placebo-controlled, crossover trial. Lancet Diabetes Endocrinol. 2018 Jan;6(1):27-40. doi: 10.1016/S2213-8587(17)30359-5. Epub 2017 Nov 2.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PROCEED
- 2011-001713-14 (Número EudraCT)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Diabetes tipo 2
-
Jin-Hee AhnAsan Medical CenterDesconocidoAmplificación del gen HER-2 | Sobreexpresión de proteína HER-2
-
The University of Tennessee, KnoxvilleTerminadoProfesores de Matemáticas (Grados 2-8) | Estudiantes de Matemáticas (Grados 2-8)Estados Unidos
-
PowderMedTerminado
-
Tianjin Medical University Second HospitalJiangsu HengRui Medicine Co., Ltd.DesconocidoTumor solido | Amplificación del gen HER-2 | Mutación del gen HER2 | Sobreexpresión de proteína HER-2Porcelana
-
AIM Vaccine Co., Ltd.Ningbo Rongan Biological Pharmaceutical Co. Ltd.; LiveRNA Therapeutics Inc.Reclutamiento
-
AIM Vaccine Co., Ltd.Ningbo Rongan Biological Pharmaceutical Co. Ltd.; LiveRNA Therapeutics Inc.Aún no reclutando
-
AIM Vaccine Co., Ltd.Aún no reclutando
-
Sunshine Guojian Pharmaceutical (Shanghai) Co.,...Aún no reclutando
-
University of PennsylvaniaInovio PharmaceuticalsReclutamiento
-
Ridgeback Biotherapeutics, LPMerck Sharp & Dohme LLCTerminado
Ensayos clínicos sobre Paricalcitol
-
Abramson Cancer Center of the University of PennsylvaniaTerminado
-
AbbottTerminadoInsuficiencia Renal CrónicaEstados Unidos, Polonia
-
Cedars-Sinai Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)ReclutamientoPancreatitis crónicaEstados Unidos
-
Chengdu Suncadia Medicine Co., Ltd.Aún no reclutando
-
Cedars-Sinai Medical CenterAbbottTerminadoSíndromes mielodisplásicos | LeucemiaEstados Unidos
-
Oslo University HospitalTerminado
-
AbbottTerminadoInsuficiencia Renal CrónicaEstados Unidos, Polonia
-
AbbottTerminadoEnfermedad renal en etapa terminal | Hiperparatiroidismo secundarioEstados Unidos
-
Dr. Reddy's Laboratories LimitedTerminado
-
AbbVie (prior sponsor, Abbott)Massachusetts General HospitalTerminadoEnfermedad Renal Crónica | Hipertrofia del ventrículo izquierdoEstados Unidos, Australia, República Checa, Alemania, Italia, Polonia, Puerto Rico, Rumania, Federación Rusa, España, Taiwán, Reino Unido