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Efficacy and Safety of Artesunate Plus Standard of Care in Active Lupus Nephritis (AURORA)

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ClinicalTrials.gov Identifier: NCT03214731
Recruitment Status : Recruiting
First Posted : July 12, 2017
Last Update Posted : February 17, 2020
Sponsor:
Collaborators:
The First People's Hospital of Yunnan
The First Affiliated Hospital of Nanchang University
General Hospital of Ningxia Medical University
First Affiliated Hospital of Fujian Medical University
Shenzhen Second People's Hospital
The Third Xiangya Hospital of Central South University
Tongji Hospital
Information provided by (Responsible Party):
Xue Qing Yu, Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE July 8, 2017
First Posted Date  ICMJE July 12, 2017
Last Update Posted Date February 17, 2020
Actual Study Start Date  ICMJE January 16, 2019
Estimated Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2017)
Remission [ Time Frame: 6 month ]
  1. Complete remission: Proteinuria < 0.3g/ 24hr, no active urinary sediment, normal albumin, stable Scr (within 15% fluctuation).
  2. Partial remission: Proteinuria between 0.3 and 2.9g /24hr and a decrease in value of at least 50% of base value, albumin≥30g/L, stable Scr (within 15% fluctuation).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Artesunate Plus Standard of Care in Active Lupus Nephritis
Official Title  ICMJE A Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Artesunate Plus Standard of Care in Active Lupus Nephritis: Pilot Study
Brief Summary

This is a multi-center, randomized, double-blind, placebo-controlled study. Study subjects are class III, IV, V, III+V, IV+V lupus nephritis patients, according to ISN/RPS 2003 classification of LN, with active lesion needing corticosteroid in combination with immunosuppressant therapy.

Subjects who meet the eligibility criteria during screening will be randomized to 1 of 3 treatment groups in a 1:1:1 ratio: 25mg bid artesunate, 50mg bid artesunate or placebo plus standard of care (prednisone plus mycophenolate mofetil [MMF]) for 6 month.

Detailed Description

Lupus nephritis (LN) can be observed in up to 70% of SLE patients and is often associated with a poor long-term prognosis. Artesunate, one analogues of antimalarial agent artemisinin, have immunomodulatory properties that might be useful for treating autoimmune diseases including SLE. it is still lack of solid evidence from RCT to evaluate efficacy and safety of artesunate plus standard of care in active LN. Regarding no data could be referred to decide the sample size and optimal dosage, we designed this pilot study. The result and experience of pilot study will answer these questions, and guarantee the multicenter RCT to be conducted successfully.

This is a multi-center, randomized, double-blind, placebo-controlled study. Study subjects are class III, IV, V, III+V, IV+V lupus nephritis patients, according to ISN/RPS 2003 classification of LN, with active lesion needing corticosteroid in combination with immunosuppressant therapy.

Subjects who meet the eligibility criteria during screening will be randomized to 1 of 3 treatment groups in a 1:1:1 ratio: 25mg bid artesunate, 50mg bid artesunate or placebo plus standard of care (prednisone plus mycophenolate mofetil [MMF]) for 6 month.

All the subjects were asked to visit the hospital for weekly follow-up for four weeks, then monthly thereafter.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Lupus Nephritis
Intervention  ICMJE
  • Drug: Artesunate
    Artesunate was produced by pharmaceutical factory for research specifically
    Other Name: Art
  • Other: placebo
    placebo was produced by pharmaceutical factory for research specifically
Study Arms  ICMJE
  • Experimental: low dose Art
    25mg bid Artesunate and standard of care was given to patients
    Intervention: Drug: Artesunate
  • Experimental: high dose Art
    50mg bid Artesunate and standard of care was given to patients
    Intervention: Drug: Artesunate
  • Placebo Comparator: placebo
    Placebo and standard of care was given to patients
    Intervention: Other: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 8, 2017)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2020
Estimated Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 1, Subjects of either sex, 14-65 years of age, 2, Diagnosis of SLE according to the ACR criteria (1997), 3, Renal biopsy within 6 months prior to randomization with a histological diagnosis (ISN/RPS 2003 classification of LN) class III, IV, V, III+V and IV+V [excluding Class III(C), IV-S(C), and IV-G(C)], 4, Class IV or IV+V LN: proteinuria ≥1g/24hr (or Urinary protein: creatinine ratio≥ 1.0) or Scr>1.3mg/dl, with active urinary sediment [> 5 RBCs/hpf or> 5 WBCs/hpf (or within the reference range of the laboratory) in absence of menses and genitourinary tract infection, or presence of cellular casts (RBC or WBC casts)], 5, Class III, III+V or V LN: proteinuria ≥2g/24hr (or Urinary protein: creatinine ratio ≥ 2.0) or Scr>1.3mg/dl, 6, Provision of written informed consent by subject or guardian.

Exclusion Criteria:

  1. eGFR<30ml/min/1.73m2,
  2. Subjects who have previously failed both MMF (or other forms of mycophenolate) induction therapies,
  3. Subjects who received an induction therapy with CTX or MMF within 3 months prior to the planned initiation of the current induction for the study,
  4. Have severe active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident [CVA], cerebritis, or CNS vasculitis) requiring therapeutic intervention within 60 days of baseline (Day 0),
  5. Have acute or chronic infection requiring management based on the investigator's opinion,
  6. Pregnant, nursing or under unreliable contraceptive method,
  7. Subjects who have been on continuous dialysis starting >2 weeks before randomization into the induction phase and/or continuous dialysis with an anticipated duration >8 weeks,
  8. Have a history of kidney transplant or a plan of kidney transplant,
  9. Known hypersensitivity or contraindication to any drug products or any component of these drug products they plan to receive (e.g. Artesunate, CTX, MMF, AZA, corticosteroids),
  10. Have severe acute or chronic diseases (e.g. cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological or infectious diseases) which, in the opinion of the principal investigator, could confound the results of the study or put the subject at under risk,
  11. Have a history of malignant neoplasm within the last 5 years, except for adequately treated carcinoma in situ of the uterine cervix,
  12. Recruited by other trial and/or use study agent within 4 weeks.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xueqing Yu, MD, Phd 13802793488 yuxq@mail.sysu.edu.cn
Contact: Wei Chen, MD, Phd 13924150966 vvchen66@qq.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03214731
Other Study ID Numbers  ICMJE AURORA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Xue Qing Yu, Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE
  • The First People's Hospital of Yunnan
  • The First Affiliated Hospital of Nanchang University
  • General Hospital of Ningxia Medical University
  • First Affiliated Hospital of Fujian Medical University
  • Shenzhen Second People's Hospital
  • The Third Xiangya Hospital of Central South University
  • Tongji Hospital
Investigators  ICMJE Not Provided
PRS Account Sun Yat-sen University
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP