ISRCTN95017029已完成2 期
A multicentre, open-label, single-arm study to investigate the safety and efficacy of intravenous ferric carboxymaltose in haemodialysis patients with anaemia
Vifor Pharma (UK)0 个研究点目标入组 482 人开始时间: 2009年1月5日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 482
研究概览
简要总结
2010 results in: https://www.ncbi.nlm.nih.gov/pubmed/20190247 (added 28/11/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male and female HDAA patients undergoing maintenance haemodialysis (two to three haemodialysis sessions per week)
- •2. Aged 18 - 65 years of age (inclusive) (the upper limit of the age was changed from 60 years according to amendment no 2, dated 12 September 2003), either sex
- •3. Iron deficiency anaemia defined as:
- •3.1. Haemoglobin (Hb) equals 11 g/dl
- •3.2. Serum transferrin saturation (TfS) less than 20% or serum ferritin equals 200 ng/ml (changed according to amendment no 2, dated 12 September 2003)
- •4. Clinically stable, without a history of admission to hospital due to renal decompensation during the 4 weeks preceding the inclusion date
- •5. Patients who were being treated with EPO, were to have received this treatment for at least one month prior to inclusion in the study, and had to remain on stable doses during participation in the study
- •6. Patients voluntarily signed an informed consent form at the screening visit, after being informed of the purpose, aims, benefits and risks of the study
- •7. Females of childbearing potential had to use reliable forms of contraception (barrier methods, including male and female condoms, and diaphragms [cervical caps] with intravaginal spermicide [including jellies, foams and suppositories], intra-uterine device or hormonal contraceptives) in the study and up to one month after the last dose of the study medication. Non-childbearing potential would include surgically sterilised at least 6 months prior to the study or post-menopausal with no menstrual bleeding for at least 2 years prior to the study.
- •8. Permanent vascular access appropriate for haemodialysis
排除标准
- •1. Known hypersensitivity to iron polysaccharide complexes and compounds of ferric carboxymaltose
- •2. Ferritin greater than 500 ng/ml, TfS greater than 50%, Hb less than 6.5 g/dl, serum albumin less than 2.5 g/dl (changed according to amendment no 2, dated 12 September 2003)
- •3. Vitamin B12 or folic acid deficiency
- •4. Types of anaemia other than anaemia associated with chronic renal failure and iron deficiency anaemia (especially haemolytic, macrocytic, hypoplastic, or sideroblastic anaemia)
- •5. Any history or clinical findings of iron storage conditions/disorders such as haemochromatosis
- •6. Active or acute infection or malignancy
- •7. Active peptic ulcer, asthma, or rheumatoid arthritis
- •8. Treatment with an investigational drug within the 30 days prior to enrolment
- •9. Patients positive for hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus (HCV) (for Romania only there was an addition of '...and evidence for acute hepatitis, i.e. abnormal liver function test [LFT] results' according to amendment no 3, dated 19 December 2003). Justification for performing HBsAg, or anti-HCV tests on patients was that LFTs were closely monitored as a possible sign of iron toxicity. Patients with hepatitis B or C infection were excluded because of difficulties to distinguish changes in liver function due to iron toxicity from symptoms of hepatitis.
- •10. Active liver disease
- •11. Significant cardiovascular disease, including myocardial infarction within 6 months prior to study inclusion, congestive heart failure New York Heart Association (NYHA) grade III or IV, or poorly controlled hypertension according to judgement of the investigator
- •12. Endocrinologic or metabolic disorders that were not controlled according to judgement of the investigator
- •13. Blood transfusion or treatment with intravenous (i.v.) iron preparations within 4 weeks before inclusion into the study (oral iron was not allowed)
- •14. Patients who needed a blood transfusion within 2 months of the start of the study
- •15. Anticipated surgery with the exception of surgery related to vascular access
- •16. Known history of drug or alcohol abuse
- •17. Pregnancy or lactation
- •18. Patients with a body mass index (BMI) higher than 15% above the normal BMI (this criterion was deleted by amendment no 2, dated 12 September 2003)
研究者
相似试验
已完成
不适用
An observation of the peer-assisted learning method in the clinical teaching of vertigo/dizziness-related diseases for standardized residency training students in ChinaClinical teaching of vertigo/dizziness-related diseases for SRT students in ChinaISRCTN53773239Army Medical University198
已完成
不适用
A double-blind, multicentric, multinational randomised study to assess the effects of two years administration of 2 g per day of strontium ranelate versus bisphosphonate in women with postmenopausal osteoporosis on bone geometry and bone strength measured by peripheral-Quantitative Computed Tomography (p-QCT)OsteoporosisISRCTN10335153Institut de Recherches Internationales Servier (France)80
已完成
不适用
A phase 1, single-center, double-blind study of AM103 in healthy volunteersISRCTN51638237Amira Pharmaceuticals (USA)86
已完成
2 期
The efficacy, safety and tolerability of PSD502 in subjects with premature ejaculation (PE)Premature ejaculationISRCTN57186091Plethora Solutions Ltd (UK)256
已完成
2 期
A Phase II, Open-label, Randomized, Multicenter Study to Assess the Safety and Cardiovascular Effects of Myocell™ Implantation by a Catheter Delivery System in Congestive Heart Failure Patients Post Myocardial Infarction(s)Ischemic cardiomyopathyISRCTN17181395Bioheart Inc. (USA)46