EUCTR2007-001394-29-FR进行中（未招募）1 期
Multi-center, prospective trial to demonstrate Improved Metabolic control of PPEN vs DDDD in DIAbetic CAPD patients -The IMPENDIA Trial - IMPENDIA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 236
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
入选标准
- •Patients who meet ALL of the following criteria at both Screening and randomization are eligible for the study:
- •1.Male or female patients who are at least 18 years of age
- •2.Patients who have read, understood and given written Informed Consent after the nature of the study has been explained
- •3.Patients who have a diagnosis of ESRD (GFR = 15 mL/min)
- •4.Patients performing CAPD using only Dianeal, a daily prescription including at least 1 exchange of Dianeal 2.5% or 4.25% dextrose (2.27% or 3.86% glucose, respectively), for at least 30 days prior to Screening and who have no prescribed dry time
- •5.Patients who are in a stable clinical condition in the judgment of the treating physician and as demonstrated by medical history, physical examination, and laboratory testing
- •6.Incident and prevalent patients with diagnosed diabetes (Type 1 and Type 2), as verified by the treating physician, and who have received glycemic-control medication, i.e., insulin and/or oral hypoglycemic agents, for at least 90 days prior to Screening
- •7.Patients with an HbA1c > 6.0% but = 10.0% (to be determined at the Screening visit using regional central laboratories and reported according to the Diabetes Control and Complications Trial (DCCT)/National Glycohemoglobin Standardization Program (NGSP) standard)
- •8.Patients who have a blood hemoglobin concentration = 9.0 g/dL, but = 13.0 g/dL (to be determined at screening visit using local lab)
- •9.Patients with a total Kt/V = 1.7 at Screening
- •10.Patients who are expected to remain on CAPD for at least 6 months
- •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
- •Patients who have any of the following at the time of either Screening or randomization are not eligible for enrollment in this study.
- •1.Patients performing Automated Peritoneal Dialysis (APD)
- •2.Female patients who are pregnant, lactating or planning to become pregnant during the study period. Note: Female patients of childbearing potential must not be pregnant and not lactating. They must also have a negative serum human chorionic gonadotropin (hCG) pregnancy test result prior to receiving any dose of study medication (14 day window). Women of childbearing potential are defined as women less than 55 years old who have not had a partial or full hysterectomy or oophorectomy. Patients are required to use medically acceptable means of contraception during their participation in this study.
- •3.Patients with concomitant participation in any other interventional study
- •4.Patients who have used any investigational device or received any investigational drug, biologic within five half-lives of the physiological action (if drug or biologic) or 30 days prior to Screening, whichever is longer
- •5.Patients who have previously participated in this study
- •6.Patients who have previously participated in the PRePEND study
- •7.Patients who have had an acute myocardial infarction (MI) with hospitalization, coronary bypass surgery, or acute coronary ischemia with percutaneous transluminal coronary angioplasty (PTCA)/stent within the last 90 days
- •8.Patients who have had a failed kidney transplant without nephrectomy of the graft
- •9.Patients who have a history of abdominal fistulae, tumors, open wounds, herniae, or other conditions, which compromised the integrity of the abdominal wall, abdominal surface, or intra-abdominal cavity, within the last 30 days
- •10.Patients who have undergone abdominal surgery within the last 30 days except for PD catheter insertion
- •11.Patients who are receiving or have received Calcineurin inhibitors (e.g., cyclosporin) or corticosteroids within the last 90 days
- •12.Patients who have any other serious acute or active conditions that in the investigator’s opinion would preclude their participation in the study
- •13.Patients who have a history of drug, or alcohol abuse in the last six months
- •14.Patients who have active liver disease such as cirrhosis of the liver, active hepatitis or other active liver disease as evidenced by biopsy, laboratory (unstable liver enzymes over the last 90 days) or clinical examination
- •15.Patients who have active infectious conditions, including but not limited to septicemia and pneumonia, within the last 90 days
- •16.Patients who have ongoing clinically significant congestive heart failure (New York Heart Association [NYHA] class III or IV)
- •17.Patients who have malignancy or other severe co-morbidity associated with a life expectancy of less than 1 year
- •18.Patients who have had an episode of life threatening systemic infection, or other serious disease, such as active, or previously treated, residual malignancy (exceptions - malignant free for two years or life threatening systemic infection free for 90 days)
- •19.Patients who have any medical condition that, in the judgment of t
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