PACTR202103526168929尚未招募2 期
Multicentre randomized double-blind placebo-controlled study to evaluate the effect on albuminuria of 6months treatment with hydroxycarbamide (Siklos®) or a placebo in adults with sickle cell disease:SIKAMIC (SIklos on Kidney function and AlbuMInuria Clinical trial)
ADDMEDICA S.A.S.0 个研究点目标入组 120 人开始时间: 2021年1月28日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •The inclusion criteria are to be verified at the screening and inclusion visits (V1and V2).
- •Patients must meet ALL the following inclusion criteria to participate in the study:
- •1.Signed and datedInformed Consent Form(ICF)by a legally competent patient.
- •2.Patients above 18years.
- •3.Patients with HbSS or HbSß0 SCD.
- •4.Patients with a value of albuminuria, assessed by ACR,over 3 mg/mmol and inferior to 100 mg/mmol confirmed by 3 positive urine samples taken one day apart.
- •5.Female patients of childbearing or postmenopausal female with last period < 12 months before screening agreeing to use a highly effective form of contraception (oral, injected or implanted hormonal contraception, intrauterine device, diaphragm, condom) during the trialand for 3 months after hydroxycarbamide discontinuation.
- •6.Male patients with partners of childbearing potential agreeing to use aneffective contraceptionduring the studyand for 3months after hydroxycarbamide discontinuation. Men with pregnant or lactating women should be advised to use barrier method contraception (condom) to prevent the foetus or neonate from exposure to hydroxycarbamide.
- •7.Patients who are covered by insurance scheme accordingto local regulatory requirements
排除标准
- •The exclusioncriteria are to be verified at the screening and inclusion visits (V1and V2).
- •Patients meeting ATLEAST one of the following exclusion criteria must not be enrolled in the study:
- •1.Patients who had severe VOC requiring hospitalisation or ACS within the last 4 weeks preceding screening visit.
- •2.Patients treated with hydroxycarbamide for any reason within the previous 6months.
- •3.Patients who have had chronic blood transfusion or transfusion in the last 3months.
- •4.Patients without any semen cryopreservation performed except vasectomised patients.
- •5.Patients with a history of hypertension (systolic blood pressure =140 or diastolic blood pressure =90mmHg)treated with antihypertensive agent belonging to pharmacological class RAS inhibitor.
- •6.Patients who have symptoms suggestive of urinary tract infection or patients with gross haematuria.
- •7.Patients with a concomitant primary kidney disease.
- •8.Patients with any systemic condition that could result in a glomerulopathy not related to SCD (e.g.diabetes mellitus, active hepatitis B or C infections, systemic lupus erythematosus, inflammatory arthropathies).
- •9.Patient with a stage 3, 4 or 5 chronic kidney disease (eGFR<60 mL/min per 1.73m2).
- •10.Patients with eGFR = 140 ml/min/1,73m² (due to the lack of information regarding the magnitude, direction and significance of the trends in eGFR evolution that couldbe expected in this population).
- •11.Patients requiring long-term treatment with drugs potentially nephrotoxic (see non-exhaustive list).
- •12.Patients requiring ACEinhibitors or ARBs within the 3months before inclusionregardless of the indication.
- •13.Patients requiring long-term treatment with non-steroidalanti-inflammatory drugs.
- •14.Patients who have treatment which can modify the kidney function (see non-exhaustive list) in the last 3 months.
- •15.Patients known to be infected with HIV.
- •16.Female patients who are pregnant or lactating.
- •17.Unreliable patients including non-compl
研究者
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