ITMCTR2100004723招募中1 期
A multicenter, randomized, controlled clinical trial of Hydroxychloroquine or new Tripterygium compound in the treatment of IgA nephropathy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 —（—）
- 性别
- All
入选标准
- •1.Aged >18 years;
- •2.Primary IgA nephropathy confirmed by renal biopsy;
- •3.After 3 months of treatment with the maximum tolerated dose of RAS blocker recommended by treatment guidelines, urinary protein was still greater than 0.75g/d;
- •4.eGFR >= 30 mL/min/1.73m^2.
排除标准
- •1.IgA nephropathy patients with indications of hormonal and immunosuppressive therapy, such as:
- •(1) Minimal pathological nephropathy with IgA deposition;
- •(2) In the past 12 months, more than 50% of glomeruli on renal biopsy had cell/cellular fibrous crescents;
- •2.Other indications of immunosuppressive therapy, such as interstitial nephritis, membranous nephropathy, etc.;
- •3.Systematic use of hormones or other immunosuppressive therapy within the past 6 months, or systematic use of hydroxychloroquine or Tripterygium wilfordii preparation within the past 6 months;
- •4.Malignant hypertension or other uncontrolled severe hypertension (systolic blood pressure > 160mmHg or diastolic blood pressure > 110mmHg);
- •5.A history of malignancy within the past 5 years, excluding treated non-melanoma skin cancer (i.e. squamous or basal cell carcinoma);
- •6.Other causes of renal instability, such as acute kidney injury due to heavy hematuria (past events are not excluded as causes);
- •7.Significant liver disease, such as ALT levels 2.0 times higher than the upper normal limit (ULN), or total bilirubin 1.5 times higher than the ULN;
- •8.Patients who were in lactation or prenancy or had fertility requirements;
- •9.Active systemic infection or severe infection within 1 month prior to enrolment, including HIV, hepatitis C virus, hepatitis B virus;
- •10.White blood cell count < 3.0x10^9/L, or anemia (hemoglobin level below 80g/L), platelet count below 80x10^9/L, or other blood disorders;
- •11.Patients who have evidence of active digestive tract ulcer;
- •12.Patients who complicated with fundus lesions;
- •13.Patients with G6PD deficiency or hypersensitivity to 4-aminoquinoline compounds, or with other contraindications to the use of hydroxychloroquine;
- •14.Patients who the investigator considered unable to comply with the study protocol.
研究者
相似试验
招募中
1 期
A multicenter, randomized, controlled clinical trial of efficacy and safety of xinan Guben Peiyuan formula series in the treatment of COPDChronic obstructive pulmonary diseaseITMCTR2200005834The First Affiliated Hospital of Anhui University of Chinese Medicine
进行中（未招募）
不适用
A randomized, controlled, multicenter clinical trial comparing the efficacy of Peginterferon alfa-2a and ribavirin and metformin versus Peginterferon alfa-2a and ribavirin for the treatment of naïve patients with chronic hepatitis C (CHC) and insulin resistance. - NDCHRONIC ACTIVE HEPATITIS C ASSOCIATED WITH INSULIN RESISTANCEMedDRA version: 6.1Level: PTClassification code 10019744EUCTR2005-003853-29-ITAZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO
招募中
不适用
Effectiveness of Bi-Sai-Tong solution for moderate to severe allergic rhinitis: a randomized controlled studyallergic rhinitisITMCTR1900002527Guangdong Provincial Hospital of Chinese Medicine
进行中（未招募）
不适用
Study comparing the use of a medical procedure (endoscopic band ligation) versus a drug treatment (carvedilol) to prevent bleeding of esophageal varices in patients with liver disease.Esophageal variceal bleeding in patients with cirrhosisEUCTR2011-006208-11-ESCAIBER
进行中（未招募）
1 期
Study to compare the clinical and radiological efficacy of 625 mg vs 1250 mg of oral methylprednisolone in patients with multiple sclerosis in relapse.MedDRA version: 15.0Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersMultiple sclerosisEUCTR2012-001965-34-ESServicio de Neurología, HU. Germans Trias i Pujol