EUCTR2021-004192-13-NL招募中1 期
A Phase II, Multi-center, Open-Label Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of R3R01 in Alport Syndrome Patients with Uncontrolled Proteinuria on ACE/ARB Inhibition and in Patients with Primary Steroid-Resistant Focal Segmental Glomerulosclerosis - R3R01 in Alport Syndrome Patients and Primary Steroid-Resistant Focal Segmental Glomerulosclerosis
River 3 Renal, Corporation0 个研究点目标入组 50 人开始时间: 2022年7月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
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
- 性别
- All
入选标准
- •All Patients:
- •1. Patient is able to communicate well with the investigator, understands
- •and is willing to comply with all requirements of the study, and
- •understands and signs the written informed consent form (ICF).
- •2. For children to be eligible, one or both parents/legal guardians must
- •sign a parental permission form which provides information contained in
- •the ICF. Children capable of assent must express their willingness to
- •participate by signing an assent form.
- •3. If patient has received a COVID vaccination, the baseline visit must
- •occur at least one week or more after the second/booster vaccination.
- •4. Patients who have had active symptoms of COVID within 3 months
- •prior to screening and are now asymptomatic for the last 2 weeks but
- •have tested COVID PCR positive. If a patient is asymptomatic at
- •screening but is COVID positive, then rescreening can occur after a
- •minimum of two weeks.
- •5. Both female patients, as well as female partners of male patients who
- •are of child-bearing potential must be willing to not become pregnant for
- •the complete duration of the study (>180 days) (90 days after the last
- •dose of study medication).
- •6. Males (including sterilized subjects) whose female partners have
- •child-bearing potential, must agree to use male contraception (condoms)
- •during the period from the time of signing the informed consent form
- •(ICF) through 90 days after the last dose of study drug. They must agree
- •to immediately inform the investigator if their partner becomes pregnant
- •during the study.
- •AS Inclusion Criteria (in addition):
- •7. Males and females with X-Linked AS and males and females with
- •autosomal inherited AS.
- •a. For countries that are enrolling pediatric patients: patients from age
- •12 years and older.
- •b. For countries that are not enrolling pediatric patients: patients from
- •age 18 years and older.
- •8. Confirmed diagnosis of AS by genetic testing and /or kidney biopsy.
- •For patients enrolled in the US who meet all inclusion and exclusion
- •criteria but have not had their diagnosis confirmed by genetic testing or
- •kidney biopsy, the Sponsor will provide for patient's genetic testing.
- •9. UPCR =1.0 g/g.
- •10. eGFR = 45 mL/min/1.73m2 (using CKD-EPI equation for adults and
- •Bedside Schwartz equation for children).
- •11. ACEi/ARB therapy at maximum tolerated dose stable for at least 4
- •weeks prior to screening. ACEi/ARB dose should remain stable over the
- •course of the study.
- •FSGS Inclusion Criteria (in addition):
- •12. Male or female patients,
- •a. For countries that are enrolling pediatric patients: 12 to 75 years old
- •at the time of signing the informed consent
- •b. For countries that are not enrolling pediatric patients: 18 to 75 years
- •old at the time of signing the informed consent
- •13. Primary FSGS (without any identifiable cause, and where the FSGS is
- •confirmed by renal biopsy) or FSGS where there is documentation of a
- 另有 12 项未显示
排除标准
- •1. Uncontrolled diabetes mellitus as evidenced by an HbA1c = 11%.
- •For Germany: HbA1c = 8.5%.
- •2. Uncontrolled hypertension
- •a. Adults: (SBP = 180mmHg and/or DBP = 100mmHg).
- •For Germany: (SBP = 140mmHg and/or DBP = 100mmHg).
- •b. Children: = 95th percentile or = 130/80 mm Hg, whichever is lower,
- •as defined in Appendix 13.8.
- •3. Moderate or severe hepatic impairment as per Child Pugh score (See
- •Section 9.5.4.7), except if (a) decreased serum albumin is directly
- •related to the renal disease (resulting in a Child Pugh score of 7), and
- •(b) no other Child-Pugh Score parameters are increased and (c) patient
- •has no liver pathology in medical history.
- •4. Presence of any active (i.e., with symptoms) and/or uncontrolled
- •infection (including COVID).
- •5. Presence of Human immunodeficiency virus (HIV).
- •6. BMI > 40. For Germany: BMI > 35 (Obesity Class II).
- •7. History of malignancy other than treated basal cell or squamous cell
- •skin cancer within the past 5 years.
- •8. History of alcohol abuse in the last 5 years or currently drinks in
- •excess of 21 and 14 units per week for males and females, respectively.
- •9. Received an investigational agent within 30 days or 5 half-lives prior
- •to screening (whichever is longer).
- •10. History of non-compliance such that patient is unlikely to be
- •compliant with study visits, procedures or drug administration.
- •11. Patient has had an organ transplant, is currently on an organ
- •transplant waiting list or there is a reasonable possibility that the
- •patient will have an organ transplant in the 6 months after screening.
- •12. Participation in an interventional trial within the previous 3 months
- •prior to screening or concurrent participation in a research trial.
- •13. Patient is not suitable to participate in the study for any reason
- •(including, but not limited to co-morbidities, history of non-compliance
- •with study visits, procedures, or drug administration) in the opinion of
- •the investigator.
- •14. Females of childbearing potential (those who are not surgically
- •sterilized or post-menopausal for at least 1 year) are excluded from
- •participation in the study unless they agree to use highly effective
- •contraception as described in Section 13.3.
- •15. Females that are lactating.
- •16. History of hypersensitivity to study drug and/or any of its excipients.
- •17. Patients with hereditary galactose intolerance, total lactase
- •deficiency or glucose-galactose malabsorption.
- •18. Required concomitant use of bardoxolone, rituximab, cyclophosphamide,
- •abatacept, or sparsentan
- •AS Exclusion Criteria (in addition):
- •19. Kidney disease apart from AS, e.g., diabetic nephropathy or lupus
- •20. Use of Bardoxolone or sparsentan treatment in the 30 days prior to
- •screening. SGLT2 inhibitors are allowed if the patient is on a stable dose
- •for at least 3 months prior to screening.
- •FSGS Exclusion Criteria (in addition):
- •21. Patient has collapsing variant of FSGS on renal biopsy.
- 另有 9 项未显示
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