NL-OMON34407已完成3 期
A 24-month, multi-center, open-label, randomized, controlled trial to investigate efficacy, safety and evolution of cardiovascular parameters in de novo renal transplant recipients after early calcineurin inhibitor to everolimus conversion (CRAD001A2429, ELEVATE study) - ELEVATE
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 90
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
- 年龄范围
- 18 至 99（—）
入选标准
- •At baseline:
- •* 18 years and above.
- •* 1st or 2nd renal transplantation from a cadaveric or living unrelated-/related donor.
- •* Negative pregnancy test (if relevant).
- •At randomization:
- •* Use of a CNI (tacrolimus or cyclosporin) plus sodium mycophenolate plus steroids.
- •* Serum creatinin less than 250 *mol/l and actual eGFR (MDRD4) at least 25 mL/min/1.73 m2
排除标准
- •At baseline:
- •* Recipient of multiple organ transplants.
- •* Recipient of ABO incompatible allograft or a positive cross-match.
- •* Patient with current Panel Reactive Antibodies (PRA) level * 30 %.
- •* HIV, hepatitis B or C (AST/ALT *2,5 x ULN) positive.
- •* Organ from a HIV or hepatitis B or C positive donor.
- •* Severe restrictive or obstructive pulmonary disease.
- •* Severe hypercholesterolaemia of hypertriglyceridaemia.
- •At randomization:
- •* Graft loss.
- •* Renal replacement therapy.
- •* Serious humoral and/or cellulare rejection.
- •* 2 or more episodes of acute rejection or an episode that needed antibody treatment.
- •* Ongoing- or currently treated acute rejection (2 weeks prior to randomization).
- •* Proteïnuria more than 1 g/day.
- •* Severe hypercholesterolaemia of hypertriglyceridaemia.
- •* Impaired would healing.
- •* Serious immunosuppressive complications or side effects.
- •* Anticoagulants as contraindication for a renal biopsy.
研究者
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