NL-OMON41833已完成2 期
A Phase 2, Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of ASP8232 as Add-On Therapy to Angiotensin Converting Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) in Reducing Albuminuria in Patients with Type 2 Diabetes and Chronic Kidney Disease. - ALBUM
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 7
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Male or female subject who is >=18 and <= 85 years of age.
- •2. Subject must have a eGFR (based on the CKD-EPI equation) at screening of >= 25 and < 75 mL/min/1.73m2.
- •3. Subject must have a documented diagnosis of T2DM and received anti-diabetic medication (oral and/or parenteral) for at least one year prior to screening.
- •4. Subject*s HbA1c level is < 11.0% at screening.
- •5. Subject is on a stable therapy with an ACE inhibitor or ARB for at least three months prior to screening.
- •6. Subject who receives anti-hypertensive treatment, non-insulin anti-diabetic agents and/or vitamin D receptor activators at screening needs to be on stable therapy for at least three months prior to screening.Subjects on insulin therapy may have the insulin type/dose/schedule adjusted even during the 3 months prior to screening.
- •7. If the subject has been subjected to specific dietary interventions then this has to be stable over
- •the past three months prior to screening visit.
- •8. Subject*s UACR is >= 200 and <= 3000 mg/g at screening AND the geometric mean UACR of all FMV samples at visit 4 and at visit 5 is >= 200 and <= 3000 mg/g AND the UACR in at least 3 FMV samples at visit 4 and visit 5 is >= 200 mg/g.
- •9. Female subject must either:
- •* Be of non child bearing potential:
- •* post-menopausal (defined as at least 1 year without any menses) prior to Screening, or
- •* documented surgically sterile or status post hysterectomy (at least 1 month prior to
- •* Or, if of childbearing potential:
- •* must have a negative pregnancy test at Screening, and
- •* must use two forms of birth control* (at least one of which must be a barrier method)
- •starting at Screening and throughout the study period and for 24 weeks after the final
- •study drug administration.
- •10. Female subject must not be breastfeeding at Screening or during the study period, and for
- •24 weeks after the final study drug administration.
- •11. Female subject must not donate ova and male subject must not donate sperm starting at Screening and throughout the study period, and for 24 weeks after the final study drug administration.
- •12. Subject agrees not to participate in another interventional study after signing the informed
- •consent and until the end of study visit has been completed.
- •13. Subject must have the ability, in the opinion of the investigator, and willingness to return for
- •all scheduled visits and perform all assessments.
排除标准
- •1. Subject has received investigational therapy within 28 days prior to Screening.
- •2. Subject has other condition which, in the investigator*s opinion, makes the subject unsuitable for study participation.
- •3. Subject is on, or previously received, renal replacement therapy (e.g. dialysis or kidney transplantation).
- •4. Subject has significant obstructive uropathy or other causes of renal impairment not related to parenchymal renal disorder and/or disease of the kidney; or subject currently has or has had in the past renal disease secondary to malignancy.
- •5. Subject*s renal impairment and/or albuminuria is considered to be of other origin than Diabetic Kidney Disease
- •6 Subject has known (auto-) immune disorder and/or received immunosuppression for more than two weeks, cumulatively, within 12 weeks prior to screening or anticipated need for immuno-suppressive therapy during the study
- •7. Subject has active urinary tract infection which requires treatment or clinically significant infection at the time of screening or randomization
- •8. Subject is diagnosed with type 1 diabetes mellitus or diabetes mellitus with unclear etiology.
- •9. Subject has a supine systolic blood pressure (SBP) <90 or >160 mmHg and/or a diastolic blood pressure (DBP) >90 mmHg at screening.
- •10. Female subject who is pregnant or lactating or has a positive pregnancy test within 72 hours prior to screening and/or randomization or has been pregnant within 6 months before screening assessment or breastfeeding within 3 months before screening or who is planning to become pregnant within the total study period.
- •11. Subject has a known or suspected hypersensitivity to ASP8232, or any components of the
- •formulation used.
- •12. Subject is an employee of the Astellas Group or CRO involved in the study.
研究者
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