CTRI/2013/01/003325已完成3 期
A prospective, international, multicenter, open-label, randomized, comparative study of efficacy and safety of Relipoietin (Reliance Life Sciences Pvt. Ltd., India) and of medicinal drug Eprex® (Cilag AG, Switzerland) in the treatment of anemia in patients with chronic kidney disease on hemodialysis - Nil
OK BETA PHARMACEUTICALS I PVT LTD0 个研究点目标入组 50 人开始时间: 待定最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
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
入选标准
- •1)Written informed consent.
- •2)End stage of chronic kidney disease.
- •3)The need for hemodialysis for at least
- •the last 3 months before inclusion
- •in the study.
- •4)The need for standard hemodialysis with total duration of at least 12 hours per
- •5)The established efficacy of hemodialysis.
- •Hemoglobin <110 g/L
- •6)Transferrin saturation >20%, Ferritin level >100 ng/ml
- •7) Ability of patient, according to the Investigator, to comply with the
- •protocol procedures
- •8)Readiness of patients with preserved
- •reproductive function to use
- •reliable methods of contraception
排除标准
- •1)The use of any erythropoiesis-stimulating agents (other erythropoietins, androgens) within 8 weeks prior to study entry.
- •2)Blood transfusion within four weeks prior to study entry.
- •3)Any other genesis of anemia, with the
- •exception of renal (folic acid and B12-deficiency anemia, and other types of
- •4)Anemia of chronic disease (activity of
- •C-reactive protein > 10 mg / l)
- •5)Refractory anemia in the presence of
- •blast transformed cells in peripheral blood
- •6)Diagnosed lupus nephritis or chronic
- •kidney disease in patient developed as a consequence of systemic angiitis;
- •7)Presence of neutralizing antibodies to
- •erythropoietin.
- •8)Vaccination within 8 weeks before study entry
- •9)Hepatic cirrhosis complicated with portal
- •hypertension, and/or splenomegaly, and/or
- •9)HIV-infection, advanced Hepatitis Ð?, С
- •10)Activity of ALAT, AST > 3ULN
- •11)Epilepsy (including in past medical history)
- •12)Obliterative peripheral vascular disease
- •13)Porphyria
- •14)Confirmed bone marrow fibrosis
- •15)Acute decompensated heart failure 16)Uncontrolled hypertension
- •17)Unstable angina
- •18)Diagnosed severe secondary hyperparathyroidism
- •19)Episodes of gastrointestinal bleeding in history
- •20)Episodes of thrombosis in history (acute
- •myocardial infarction, stroke,
- •transient ischemic attacks, deep vein
- •thrombosis, pulmonary embolism)
- •within six months prior to study entry, as well
- •as an increased risk of deep vein thrombosis
- •21)History of acute hemolytic episodes
- •22)Abdominal operation within 1 month prior to
- •study entry
- •23)Any acute inflammatory disease or
- •exacerbation of chronic diseases,
- •including identified foci of septic and aseptic
- •inflammation
- •24)Malignancy, except cured basal cell carcinoma
- •and cervical cancer in situ; any malignancy
- •with a duration of complete remission for more
- •than 5 years
- •25)Drug addiction, alcohol abuse
- •26)Hypersensitivity to Epoietin alpha or to
- •any components of study drugs
- •27)Pregnancy or lactation
- •28)Simultaneous participation in other clinical trials, and prior participation in other clinical trials within 3 months before inclusion in this clinical study
研究者
相似试验
进行中（未招募）
1 期
An International, Multicentre, Prospective, Single Arm Study to Assess the Effect on Voluntary Movements of AbobotulinumtoxinA 1500 U Administered in Both Upper and Lower Limbs in Conjunction with a Guided Self Rehabilitation Contract in Adult Subjects with Spastic HemiparesisEUCTR2016-001989-29-CZIpsen Pharma155
进行中（未招募）
1 期
An International, Multicentre, Prospective, Single Arm Study to Assess the Effect on Voluntary Movements of AbobotulinumtoxinA 1500 U Administered in Both Upper and Lower Limbs in Conjunction with a Guided Self Rehabilitation Contract in Adult Subjects with Spastic HemiparesisEUCTR2016-001989-29-FRIpsen Pharma SAS157
尚未招募
不适用
An international, multicenter prospective single arm study to investigate procedural, clinical and angiographic outcomes using the Taxus Liberte stent, with improved side branch access, following the provisional side branch T-stenting approach, in patients with complex lesions.complex coronary lesions (involving side branches)NL-OMON21479Dr. Phillipe Brunel400
进行中（未招募）
1 期
A prospective, international, multi-centre, open-label, phase II study investigating the utility of [68Ga]Ga-PentixaFor PET imaging in response assessment (evaluation of the tumour response to the applied therapy) of primary (primary tumour in brain) and isolated secondary (secondary tumour in brain after relapse of a primary tumour not located in the brain) CNS lymphoma patientsCentral nervous system (CNS) lymphomaMedDRA version: 21.1Level: PTClassification code 10028997Term: Neoplasm malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-001711-85-NLPentixaPharm GmbH50
撤回
2 期
A prospective, international, multi-centre, open-label,single-arm phase II study investigating the predictive value of [68Ga]Ga-PentixaFor PET imaging in primary and isolated secondary CNS lymphoma patientsCentral Nervous system lymphomaBrain lymphoma10025322Brain tumorNL-OMON51764PentixaPharm GmbH6