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 - Salt intake and antiproteinuric effect of Paricalcitol in type 2 diabetes

IST. DI RICERCHE FARMACOLOG. M. NEGRI0 个研究点目标入组 115 人开始时间: 2012年3月20日最近更新: 2019年11月25日

研究概览

暂无简介。

•- 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 with losartan 100 mg/day since at least one month; - Written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 82
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•- Previous Vitamin D or Vitamin D analogs therapy (within 3 months prior to the study entry); - 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.

发起方

IST. DI RICERCHE FARMACOLOG. M. NEGRI