EUCTR2007-001394-29-PT进行中（未招募）不适用
Multi-center, Prospective, Randomized Trial to Demonstrate Improved Metabolic Control of Physioneal, Extraneal, Nutrineal (P-E-N) vs Dianeal Only Treatment in Diabetic CAPD and APD Patients – The IMPENDIA Trial. (Revised per Amendment A.) - IMPENDIA
BAXTER HEALTHCARE CORPORATIO0 个研究点目标入组 236 人开始时间: 2007年12月6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
- 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
- 性别
- All
入选标准
- •Revised per Amendment A:
- •3. Patients who have a diagnosis of ESRD (GFR = 15 mL/min). Re-test will be allowed within 14 days.
- •4. Patients performing CAPD or APD using only Dianeal and/or Physioneal, a daily prescription including at least 1 exchange or bag of 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.
- •6. Incident and prevalent patients with diagnosed diabetes (Type 1 and Type 2), as verified by the treating physician
- •7. Patients with an HbA1c > 6.0% but = 12.0% (to be determined at the Screening visit using regional central laboratories and measured according to the Diabetes Control and Complications Trial (DCCT)/National Glycohemoglobin Standardization Program (NGSP) standard). The HbA1c result will be reported as Pass or Fail to indicate that the HbA1c either meets or does not meet the inclusion criteria.
- •8. Patients who have a blood hemoglobin concentration = 8.0 g/dL, but = 13.0 g/dL (to be determined at screening visit using local lab). Re-test will be allowed within 14 days.
- •9. Patients with a total Kt/V = 1.7 at Screening. Re-test will be allowed within 14 days.
- •10. Patients who are expected to remain on CAPD or APD 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
- •Revised per Amendment A:
- •Excl.Criteria 1 is deleted.
- •10.Patients who are receiving or who have received oral or intravenous immunosuppressants (e.g., calcineurin inhibitors such as tacrolimus or cyclosporin, mycophenolate, azathioprine) or oral or intravenous corticosteroids within the last 90 days.
- •14.Patients who have active infectious conditions that require i.v. antibiotics or hospitalization, including but not limited to septicemia and pneumonia, within 90 days prior to the Screening visit, Day 1 (counted from last day of antibiotic treatment); or patients who have active infectious conditions that require oral antibiotics (without hospitalization), within 14 days (counted from last day of antibiotic treatment).
- •15.Patients who have ongoing clinically significant congestive heart failure (New York Heart Association [NYHA] class III or IV), as judged by the investigator.
- •23.Patients who have received antibiotics within 30 days of the first screening visit (counted from last day of antibiotic treatment) for the treatment of peritonitis. Note: patients who have received antibiotic infection prophylaxis (i.e., during the insertion of a PD catheter) are not excluded from enrollment.
- •28.Patients with a serum urea > 30 mmol/L at Screening Day 2. Re-test will be allowed within 14 days.
- •29.Patients who have been exposed to Extraneal, or Nutrineal within 60 days prior to Screening visit, Day 1.
研究者
相似试验
进行中（未招募）
不适用
Multi-center, Prospective, Randomized Trial to Demonstrate Improved Metabolic Control of PPEN vs DDDD in Diabetic CAPD Patients - The IMPENDIA trial - IMPENDIAEUCTR2007-001394-29-ITBaxter Healthcare Corporation236
已完成
4 期
A Prospective, Randomized, Multi-center Trial to Assess the Everolimus-Eluting Coronary Stent System (PROMUS Element) for Coronary Revascularization in a Population of Unrestricted PatientsCoronary artery diseaseatherosclerotic heart disease10011082NL-OMON35665European Cardiovascular Research Center CERC100
招募中
不适用
A Prospective, Multicenter, Randomized Trial of New Cutting Balloon Versus Conventional Balloon for the Treatment of Severe Calcified LesioIschemic heart diseasecoronary artery diseaseJPRN-jRCTs052200044Koyama Kohei170
已完成
3 期
A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element*) for the Treatment of up to two De Novo Coronary Artery LesionsatherosclerosisNL-OMON33929Boston Scientific Cooperation International100
尚未招募
1 期
A Multicenter, Randomized and Controlled Trial for Chang-An-Jun-Tai Granule in the Treatment of Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D).Irritable bowel syndromeITMCTR1900002644The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine