EUCTR2011-005224-18-DE进行中（未招募）不适用
Intravenous Ferric Carboxymaltose for improvement of metabolic parameters and vascular function in T2DM patients with iron deficiency - CLEVER
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- GWT-TUD GmbH
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Type 2 Diabetes mellitus
- •-Ferritin <150 ng/ml or TSAT <25% if Hb <14 g/dl
- •- Ferritin <100 ng/ml or TSAT <20% if Hb =14 g/dl and=15g/dl]
- •- HbA1c (%) = 6.5 to < 8.5
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 152
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 152
排除标准
- •Continuous subcutaneous insulin infusion (CSII)
- •Thalassaemia
- •Hb> 15 g/dl
- •Change of HbA1c of more than ±0,3 % within the last 3 months.
- •Hypersensitivity to the active substance, to Ferinject® or any of its excipients
- •Known serious hypersensitivity to other parenteral iron products
- •History of acquired iron overload
- •History of erythropoietin stimulating agent, i.v. iron therapy, and/or blood transfusion in previous 12 weeks prior to randomisation
- •History of oral iron therapy at doses = 100 mg/day 1 week prior to randomisation. Note: Ongoing oral use of multivitamins containing iron < 75 mg/day is permitted.
- •Body weight = 40 kg
- •CRP > 15 mg/l.
- •Chronic liver disease (including known active hepatitis) and/or screening alanine transaminase (ALAT) or aspartate transaminase (ASAT) > 3 x ULN (upper limit of the normal range).
- •Subjects with known hepatitis B surface antigen positivity and/or Hepatitis C virus ribonucleic acid positivity.
- •Vitamin B12 and/or serum folate deficiency. If deficiency corrected subject may be rescreened for inclusion.
- •Subjects with known seropositivity to human immunodeficiency virus.
- •Clinical evidence of current malignancy with exception of basal cell or squamous cell carcinoma of the skin, and cervical intraepithelial neoplasia (5 years prior to randomization)
- •Currently receiving systemic chemotherapy and/or radiotherapy.
- •Renal dialysis (previous, current or planned within the next 6 months).
- •Renal function GFR < 30 mL/min/ 1.73m2 (severe)
- •Unstable angina pectoris as judged by the Investigator; severe valvular or left ventricular outflow obstruction disease needing intervention; atrial fibrillation/flutter with a mean ventricular response rate at rest >100 beats per minute.
- •Acute myocardial infarction or acute coronary syndrome, transient ischaemic attack or stroke within the last 3 months prior to randomization.
- •Coronary-artery bypass graft, percutaneous intervention (e.g., cardiac, cerebrovascular, aortic; diagnostic catheters are allowed) or major surgery, including thoracic and cardiac surgery, within the last 3 months prior to randomisation.
- •Patients with a polyneuropathy without ischemia.
- •Female subject of child-bearing potential who is pregnant (e.g., positive human chorionic gonadotropin test) or is breast feeding.
- •Any subject not willing to use adequate contraceptive precautions* during the study and for up to 5 days after the last scheduled dose of study medication.
- •Participation in other interventional trials
- •Failure to use highly-effective contraceptive methods*
- •Persons with any kind of dependency on the investigator or employed by the sponsor or investigator
研究者
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