NCT00502242已完成4 期
A Randomized, Placebo Controlled, Double-Blind Comparative Study Evaluating The Effect of Ramipril On Urinary Protein Excretion In Maintenance Renal Transplant Patients Converted To Sirolimus
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 229
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Had Initiated Losartan Therapy at 52 Weeks Following Conversion to SRL
研究概览
简要总结
The primary objective of the study is to determine the efficacy of ramipril in preventing a urinary protein to creatinine ratio (U p/c) greater than 0.5 following conversion to sirolimus from a calcineurin inhibitor (CNI) in maintenance kidney transplant patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving cyclosporine (CsA) or tacrolimus (TAC) since the first month post-transplant.
- •In addition to a calcineurin inhibitor (CNI), subjects must be treated with either corticosteroids at a dosage range of 2.5 to 15 mg/day for prednisone or prednisolone (2 to 12mg/day for methylprednisolone or the alternate day equivalent) or a steroid-free regimen for a minimum of 12 weeks before randomization or either MMF (>/=500mg/day), mycophenolate sodium (MPS) (>/=360 mg/day) or AZA (>/=50mg/day). Subjects must be taking a minimum of 2 immunosuppressive drugs if on a steroid-free regimen.
- •Subject is 3 to 60 months after renal transplantation.
- •Subject is greater than 12 weeks after treatment for any acute rejection.
排除标准
- •Subjects who are currently receiving, or have received within 4 weeks before enrollment, RAAS blockade.
- •Subjects with a calculated GFR < 40mL/min (per the Modification of Diet in Renal Disease [MDRD-7] or abbreviated MDRD formula).
- •Subjects with a urine protein to creatinine ratio (U p/c) of >0.
- •Subjects with a history of uncontrolled systolic blood pressure (SBP >140 mm Hg).
- •Subjects with severe hepatic impairment (Grade C Child-Pugh score). Additional Inclusion / Exclusion Criteria apply.
研究组 & 干预措施
A
Active Comparator
Capsule - initial treatment is 5 mg (active)- oral - once per day
干预措施: ramipril (Drug)
B
Placebo Comparator
Capsule - initial treatment is 5 mg (placebo) - oral - once per day
干预措施: ramipril (Drug)
结局指标
主要结局
Percentage of Participants Who Had Initiated Losartan Therapy at 52 Weeks Following Conversion to SRL
时间窗: From Day 1 of SRL conversion to 52 weeks after conversion
The event for each participant was defined as the initiation of losartan while on SRL and ramipril/placebo combination therapy. Participants who started losartan prior to SRL administration were not counted as events. Percentage was estimated using Kaplan-Meier method for time to event data.
次要结局
- Change From Baseline in Fasting Lipid Parameters (Millimoles Per Liter [mmol/L]) at 4, 12, 24, and 52 Weeks Following Conversion to SRL(4, 12, 24, and 52 weeks after conversion)
- Percentage of Participants Using Statins(Baseline, Pre-SRL (from first dose of ramipril/placebo up to SRL conversion), On-Therapy (up to 52 weeks after SRL conversion), and Off-Therapy Period (up to 56 weeks after SRL conversion))
- Percentage of Participants With an Infection(From Day 1 of Ramipril/Placebo to 52 weeks after SRL conversion)
- Percentage of Participants Who Had a Dose Escalation in Randomized Test Article (Ramipril or Placebo) by 52 Weeks Following Conversion to SRL(From Day 1 of SRL conversion to 52 weeks after conversion)
- U p/c at Baseline and Weeks 3, 4, 8, 12, 24, 30, 36, and 52 Following Conversion to SRL(Baseline and 3, 4, 8, 12, 24, 30, 36, and 52 weeks after conversion)
- Percentage of Participants With Urinary Albumin to Creatinine Ratio (U Alb/c) <0.5 at 24 and 52 Weeks Following Conversion to SRL(24 weeks and 52 weeks after conversion)
- Percentage of Participants With Both U Alb/c <0.5 and U p/c <0.5 at 24 and 52 Weeks Following Conversion to SRL(24 weeks and 52 weeks after conversion)
- Percentage of Participants With First BCAR at 24 and 52 Weeks Following Conversion to SRL(24 weeks and 52 weeks after conversion)
- Percentage of Participants With U p/c <0.5 at 24 and 52 Weeks Following Conversion to Sirolimus(24 weeks and 52 weeks after conversion)
- U Alb/c at Baseline and Weeks 3, 4, 8, 12, 24, 30, 36, and 52 Following Conversion to SRL(Baseline and 3, 4, 8, 12, 24, 30, 36, and 52 weeks after conversion)
- Percentage of Participants Who Discontinued SRL Therapy at 24 and 52 Weeks Following Conversion to SRL(24 weeks and 52 weeks after conversion)
- Fraction of Albumin (Milligrams Per Deciliter [mg/dL]) to Protein (mg/dL) in Urine at 24 and 52 Weeks After Conversion to SRL(24 weeks and 52 weeks after conversion)
- Percentage of Participants With Hemoglobin Levels ≤100 Grams Per Liter (g/L)(Baseline, Pre-SRL (from first dose of ramipril/placebo up to SRL conversion), On-Therapy (up to 52 weeks after SRL conversion), and Off-Therapy Period (up to 56 weeks after SRL conversion))
- Percentage of Participants Using Red Blood Cell Production Stimulants (Erythropoiesis Stimulating Agents [ESAs])(Baseline, Pre-SRL (from first dose of ramipril/placebo up to SRL conversion), On-Therapy (up to 52 weeks after SRL conversion), and Off-Therapy Period (up to 56 weeks after SRL conversion))
- Biopsy-Confirmed Acute Rejection (BCAR) - Number of Participants With an Event(From Day 1 of SRL conversion to 52 weeks after conversion)
- Number of Participants With BCAR by Severity of First BCAR(From Day 1 of SRL conversion to 52 weeks after conversion)
- Percentage of Participants With Graft Loss at 24 and 52 Weeks Following Conversion to SRL(24 weeks and 52 weeks after conversion)
- Percentage of Participants With Malignancy(From Day 1 of Ramipril/Placebo to 52 weeks after SRL conversion)
- Percentage of Participants With Hyperkalemia(Baseline, Pre-SRL (from first dose of ramipril/placebo up to SRL conversion), On-Therapy (up to 52 weeks after SRL conversion), and Off-Therapy Period (up to 56 weeks after SRL conversion))
- Abbreviated Modified Diet in Renal Disease (MDRD) Glomerular Filtration Rate (GFR) at Weeks 12, 24, and 52 Following Conversion to SRL(12, 24, and 52 weeks following conversion)
- Percentage of Participants With Potentially Clinically Important Blood Pressure (BP) Values by Diastolic and Systolic BP Category(Baseline, Pre-SRL (from first dose of ramipril/placebo up to SRL conversion), On-Therapy (up to 52 weeks after SRL conversion), and Off-Therapy Period (up to 56 weeks after SRL conversion))
- SRL Time-Normalized Trough Concentration (Cmin,TN) by Time Interval(From Day 1 of SRL conversion to 52 weeks after conversion)
- Percentage of Participants With Angioedema(From Day 1 of Ramipril/Placebo to 52 weeks after SRL conversion)
研究者
研究点 (1)
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