2024-512154-24-00招募中4 期
A PILOT PROOF-OF–CONCEPT STUDY TO ASSESS THE EFFICACY AND SAFETY OF A 6 MONTHS RAVULIZUMAB TREATMENT IN PATIENTS WITH FLARES OF CORTICOSTEROID-RESISTANT IDIOPATHIC IgA NEPHROPATHY
Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre, Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年6月28日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Quantitative reduction of proteinuria and haematuria (based on 24-hr urine collection(s)) from baseline to Week 26 (6 months after starting treatment with ravulizumab)
研究概览
简要总结
To determine the quantitative reduction of proteinuria and haematuria in adult participants with IgAN.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Participant must be ≥ 18 years of age at the time of signing the informed Consent and capable of giving informed consent
- •Written consent
- •Previous biopsy proven idiopathic IgAN
- •Persistent activity despite adequate standard of care treatment: a. Patients with preserved renal function: Ratio proteinuria/creatinine >1 g/g associated to haematuria > 15 cells/microliter after 6 months of treatment with corticosteroids according to the recommendations of the guidelines. b. Patients with AKI (acute kidney injury): persistence of haematuria and proteinuria and absence of improvement of renal function 4 weeks after the onset of the outbreak and treatment with 3 corticosteroid pulses of at least 250 mg followed by 1 mg/Kg/day oral prednisone Patients with evidence of extracapillary proliferation could be considered candidates for treatment with ravulizumab after treatment with the standard of care for this condition with 3 pulses of 6- methylprednisolone and at least 1 pulse of cyclophosphamide.
- •Evidence of mesangial deposition of C5b-9 with or without capillary deposits of C3d
- •Vaccination against meningococcus, haemophilus and pneumococcus
- •Participants on SGLT-2 inhibitors (eg, empagliflozin) must be on a stable dose for ≥3 months prior to Screening with no planned change in dose during the study.
- •Compliance with stable and optimal dose of RAS inhibitor treatment including maximum allowed or tolerated ACE inhibitor and/or angiotensin receptor blocker dose for ≥3 months prior to Screening with no expected change in dose during the study.
- •Absence of specific contraindications for ravulizumab treatment.
- •Female participants of childbearing potential, and male participants with female partners of childbearing potential must follow protocol specified contraception guidance as described in Appendix 4.
排除标准
- •Concomitant significant renal disease other than IgA nephropathy (eg, SLE, cirrhosis, celiac disease)
- •Patients who have received any investigational agent within the last 30 days or are in follow-up of another clinical study prior to study enrolment
- •Active psychiatric disorder, including, but not limited to schizophrenia, bipolar disorder, or severe depression requiring current pharmacological intervention
- •History of meningococcal infection within 12 months before Screening
- •Known contraindication to either of the meningococcal (group ACWY conjugate and group B vaccines), Haemophilus influenzae type b (Hib) and Streptococcus pneumonia vaccines used in this study. Refer to the most recent local product information for each vaccine for the current list of contraindications
- •Known medical history or evidence of chronic liver disease or cirrhosis
- •Known human immunodeficiency virus (HIV) infection; hepatitis C virus (HCV) infection or hepatitis B virus infection
- •Other medical conditions or comorbidities which, in the opinion of the Investigator, would interfere with study compliance or data interpretation
- •Patients who consume more than 14 units of alcohol a week (unit 1 glass of wine [125 mL] = 1 measure of spirits = ½ pint of beer)
- •Pregnant, breastfeeding, or intending to conceive during the course of the study
- •Sustained Blood pressure > 140 / 90 mmHg as defined by 2 or more readings >30 min apart during the run-in period, as measured in supine position after 10 minutes of rest
- •Estimated GFR <30 mL/min/1.73 m2 during Screening calculated by CKD-EPI
- •Secondary aetiologies of IgA nephropathy (e.g., inflammatory bowel disease, celiac disease)
- •Diagnosis of Henoch-Schonlein Purpura (IgA Vasculitis)
- •Receipt of an organ transplant (including hematologic transplant) planned or transplant during the Treatment Period
- •Clinical laboratory test results considered clinically relevant and unacceptable in the opinion of the Investigator
- •Malignancy (except for non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate cancer) within the last 5 years
- •Patients with systemic bacterial or fungal infections, as demonstrated by a positive culture result, that require systemic treatment with antibiotics or antifungals. Patients receiving empiric or prophylactic antibiotics are not excluded
结局指标
主要结局
Quantitative reduction of proteinuria and haematuria (based on 24-hr urine collection(s)) from baseline to Week 26 (6 months after starting treatment with ravulizumab)
Quantitative reduction of proteinuria and haematuria (based on 24-hr urine collection(s)) from baseline to Week 26 (6 months after starting treatment with ravulizumab)
次要结局
- Percentage of participants achieving complete remission 26 weeks after treatment with ravulizumab
- Evolution of proteinuria and haematuria (based on 24- hr urine collection(s)) after treatment withdrawal (from Week 26 to Week 46)
- To measure the evolution of serum creatinine levels (quantitative) from baseline to Week 46
- To measure the evolution of urine C5b-9 levels (quantitative) from baseline to Week 46
- To measure the slope of eGFR computed from baseline to Week 46
- Proportion of patients discontinuing treatment with ravulizumab due to adverse effects associated with the drug
研究者
Diego Arango Del Corro
Scientific
Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre
研究点 (1)
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