EUCTR2017-003021-15-FR进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects with Focal Segmental Glomerulosclerosis (FSGS)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- •1. Male or female subjects aged 18-75 years inclusive
- •2. Urinary total protein:creatinine ration (UPCR) = 1 g protein/g creatinine at screening (or UPCR at 113 mg/mmol).
- •3. Diagnosis of FSGS based on at least one of the following:
- •o Renal biopsy demonstrating the FSGS lesion and characteristic clinical presentation and course
- •o High risk genetic variant and characteristic clinical presentation and course
- •4. Diagnosis of one of the following subtypes of FSGS:
- •o Primary FSGS based on characteristic histopathology, medical history, and clinical course, or
- •o FSGS secondary to a genetic variant associated with increased risk or severity, which may include NPHS1, NPHS2, WT-1, LAMB2, CD2AP, TRPC6, ACTN4 or INF2
- •5. Estimated glomerular filtration rate (eGFR) >30 mL/min/1.73m2, with eGFR calculated
- •using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (using creatinine or cystatin C)
- •6. The typical blood pressure of the patient should be clinically stable prior to enrollment and not exceed 145/95 mmHg.
- •7. If using RAAS blockers, dose must be stable for a minimum of 4 weeks prior to Screening, and projected to remain stable through Study Week 12, unless adjustment is required for management of hypertension. Blood pressure should be clinically stable prior to enrollment.
- •8. If using immunosuppressive or immunomodulatory therapy, dose must be stable for a
- •minimum of 4 weeks prior to Screening, and projected to remain stable through Study
- •9. If using glucocorticoids, dose must be stable for a minimum of 4 weeks prior to Screening and projected to remain stable through Study Week 12
- •10. Female subjects of childbearing potential may participate if adequate contraception is used during, and for at least 5 half-lives after last dose of study drug. Male subjects with partners of childbearing potential may participate in the study if they had a vasectomy at least 6 months prior to randomization or if adequate contraception is used during, and for at least one month after the last dose of study drug. Adequate contraception is defined as resulting in a failure rate of less than 1% per year (combined estrogen and progestogen [oral, intravaginal, or transdermal], or progestogen-only hormonal contraception (oral, injectable, or implantable), intra-uterine device, intra-uterine hormone releasing system, bilateral tubal occlusion, vasectomized partner, or sexual abstinence). In addition, a barrier method (i.e. cervical cap, diaphragm or condom) must be used during intercourse between a male subject and a female of child-bearing potential.
- •11. Willing and able to give written Informed Consent and to comply with the requirements
- •of the study protocol
- •12. Judged to be otherwise fit for the study by the Investigator, based on medical history,
- •physical examination, and clinical laboratory assessments. Subjects with clinical laboratory values that are outside of normal limits (other than those specified in the Exclusion Criteria) and/or with other abnormal clinical findings that are judged by the Investigator not to be of clinical significance, may be entered into the study.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Pregnant or nursing
- •2. History of organ transplantation
- •3. Currently on an organ transplant waiting list or there’s a reasonable possibility of getting an organ transplant within 6 months of screening
- •4. Subjects that use of rituximab or other anti-CD20 monoclonal antibodies within 20 weeks prior to screening are excluded while subjects that used rituximab or other anti-CD20 monoclonal antibodies prior to 20 week of screening are allowed with confirmed recovery of CD20+ B cell population to within normal range
- •5. Plasmapheresis within 12 weeks prior to screening
- •6. Body mass index (BMI) =40
- •7. Participated in any clinical study of an investigational product within 12 weeks prior to
- •screening, or within 5 half-lives after taking the last dose of investigational product
- •8. Currently on dialysis or likely to require dialysis during the projected blinded treatment
- •period of 12 weeks
- •9. History or presence of any form of cancer within the 5 years prior to screening, with the
- •exception of excised basal cell or squamous cell carcinoma of the skin, or carcinoma in situ
- •such as cervical or breast carcinoma in situ that has been excised or resected completely and
- •is without evidence of local recurrence or metastasis
- •10. Positive HBV, HCV, or HIV viral screening test. Subjects who have received highly effective therapy for HCV demonstrated to have negative viral titers for at least 6 months
- •following discontinuation of treatment, will be considered to have a negative HCV screening test
- •11. Renal disease associated with disorders other than FSGS (e.g. lupus nephritis, C3 glomerulopathy, proliferative glomerulonephritis, IgA nephropathy, reflux nephropathy,
- •surgical segmental renal ablation, sickle cell disease ) that is active, or has significant risk of
- •progressing during the course of the study
- •12. Disorders other than those listed in Inclusion Criterion 4 that are associated with FSGS
- •lesion (e.g. single kidney, surgical segmental renal ablation, sickle cell disease, diabetic
- •nephropathy; others)
- •13. Evidence of tuberculosis based on interferon ? release assay (IGRA), tuberculin purified
- •protein derivative (PPD) skin test, or chest radiography done during screening or within 6
- •weeks prior to screening
- •14. Evidence of hepatic disease; AST, ALT, alkaline phosphatase >3x ULN, or total bilirubin > 2x ULN or INR > 1.5 x ULN at baseline prior to dosing with the exception that isolated INR elevation in the absence of other significant liver enzyme abnormalities is explained by anticoagulant therapy, (e.g. warfarin).
- •15. Clinically significant peripheral neuropathy.
- •16. Hematologic abnormalities as follows: Hb < 8 g/dL, platelets < 50,000, ANC < 1000
- •cells/µL) at baseline
- •17. Clinically significant abnormal ECG during screening, e.g., QTcF greater than 450 msec
- •18. History of alcohol or illicit drug abuse or of lithium, pamidronate and interferon. Recreational use of cannabis is not excluded where legal.
- •19. History of gastrointestinal conditions that may interfere with study medication compliance, e.g., severe gastroparesis, with regurgitation of food or oral medication
- •20. Known hypersensitivity to CCX140-B or inactive ingredients of the CCX140-B tablets
- •(including microcrystalline cellulose, starch, crospovidone, magnesium stearate, or silicon
- •21. History or presence of systemic disorder other than FSGS that requires, or is expected to
- •require, systemic glucocorticoids or immune modulators during the study; topical or inhaled
研究者
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