A prospective, randomized, cross-over,double blind study to evaluate if paricalcitol antiproteinuric effect in type 2 patients and stable RAS inhibitory therapy depens on dietary sodium intake

Phase 1

• Conditions: Type 2 diabetes; MedDRA version: 14.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2011-001713-14-IT
• Lead Sponsor: IST. DI RICERCHE FARMACOLOG. M. NEGRI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-20
• Study Completion: 2015-05-29
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 115

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 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

Exclusion Criteria

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified