EUCTR2006-001363-31-ES进行中（未招募）不适用
Estudio VITAL- Estudio del activador del receptor de la vitamina D selectivo (Paricalcitol) para la reducción de la albúmina: Estudio multicéntrico de fase II, prospectivo aleatorizado, a doble ciego y controlado mediante placebo, para evaluar la seguridad y eficacia de las cápsulas de paricalcitol en la reducción de la albuminuria en pacientes con diabetes de tipo 2 que presentan nefropatía y que están siendo tratados actualmente con inhibidores del sistema renina-angiotensina.VITAL Study-Selective VITamin D Receptor Activator (Paricalcitol) for Albuminuria Lowering Study: A Phase 2, Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Paricalcitol Capsules on Reducing Albuminuria in Type 2 Diabetic Nephropathy Subjects who are Currently Being Treated with Renin-angiotensin Sytem Inhibitors. - Not available
Abbott GmbH & Co KG0 个研究点目标入组 258 人开始时间: 2007年3月9日最近更新:
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
- 入组人数
- 258
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
- •1. Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
- •2. Male or female subjects equal to or greater than 20 years old.
- •3. Subject has Type 2 Diabetes Mellitus and has been treated with at least one anti-hyperglycemic medication within the 12 months prior to the Screening Phase.
- •4. Subject has been receiving a stable dose (i.e., same type and regimen) of ACEi and/or ARB for at least three months prior to the Screening Phase. However, subject may have switched to different brands but at equivalent doses during the three months prior to the Screening Phase.
- •5. Subject is not expected to begin dialysis for at least six months.
- •6. If female, subject is not breast feeding or is not pregnant ; or is not of childbearing potential; or is of childbearing potential and practicing a method of birth control.
- •7. For entry into the Treatment Phase the subject must satisfy the following criteria based on the Screening laboratory values:
- •a. Estimated GFR between 25-75 mL/min/1.73m2 by simplified MDRD formula.
- •b. UACR between 200 and 1800 mg/g as determined by the mean of the three spot morning urine specimens obtained within one week of each other.
- •c. Corrected serum calcium level equal to or less than 9.5 mg/dL.
- •d. iPTH value between 50-500 pg/mL.
- •e. HbA1c equal to or less than 12%.
- •f. Serum albumin > 3.0 g/dL.
- •g. Negative urine pregnancy test for female subjects.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subject has previously been on prescription-based vitamin D therapy within the six months prior to the Screening Phase.
- •2. Subject has a history of an allergic reaction or significant sensitivity to paricalcitol or to drugs similar to the study drug.
- •3. Subject has primary glomerulopephritis or secondary nephritis in addition to diabetic nephropathy.
- •4. Subject has had acute renal failure within 12 weeks of the Screening Phase defined by an acute rise in serum creatinine (of at least 0.5 mg/dL or 44 mmol/L) to more than 4 mg/dL (350 mmol/L).
- •5. Subject has chronic gastrointestinal disease, which in the Investigator's opinion may cause significant GI malabsorption.
- •6. Subject has secondary hypertension (i.e., renal artery stenosis, primary aldosteronism or pheochromocytoma).
- •7. Subject has poorly controlled hypertension (systolic blood pressure equal to or greater than 160 mmHg and or diastolic blood pressure equal to or greater than 100 mmHg).
- •8. Subject has a history of kidney stones.
- •9. Subject has a history of drug or alcohol abuse within six months prior to the Screening Phase.
- •10. Subject has evidence of poor compliance with diet or medication that may interfere, in the Investigator's opinion, with adherence to the protocol.
- •11. Subject has received any investigational drug within 30 days prior to study drug administration.
- •12. Subject is taking calcitonin, bisphosphonates, cinacalcet, glucocorticoids (except topical glucocorticoids) or other drugs that may affect calcium or bone metabolism, other than calcium containing phosphate binder or female subjects on stable (same dose and product for three months) estrogen and/or progestin therapy.
- •13. For any reason, subject is considered by the Investigator to be an unsuitable candidate to receive paricalcitol capsules or is put at risk by study procedures.
- •14. Subject is known to be HIV positive.
研究者
相似试验
招募中
Unknown
Elucidation of the role of Receptor activator of nuclear factor kappa-B (RANK)/RANK ligand (RANKL) signals in the onset and progression of primary biliary cholangitisprimary biliary cholangitisJPRN-UMIN000053038Tokai University School of Medicine40
已完成
1 期
Clinical evaluation of the new nicotinic receptor marker (-)- [18F]NCFHEB with Positron Emission Tomography in Alzheimer’s disease patients, and healthy volunteersG30Alzheimer diseaseDRKS00000472niversität Leipzig49
撤回
不适用
RRR Study: study on the role of inhibitory receptors in respiratory syncytial virus (RSV) bronchiolitisbronchiolitisNL-OMON34523niversitair Medisch Centrum Utrecht
进行中（未招募）
不适用
Safety and efficacy trial of a RNActive®-derived prostate cancer vaccine in hormone refractory diseaseEUCTR2008-003967-37-DECureVac GmbH50
招募中
1 期
Investigating the neuroreceptor NMDA in the brain of healthy and depressed peopleMajor DepressionEUCTR2022-003279-41-ATMedical University of Vienna, University Department of Psychiatry and Psychotherapy60