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Trial record 55 of 147 for:    lupus AND Lupus Nephritis

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

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ClinicalTrials.gov Identifier: NCT03214731
Recruitment Status : Not yet recruiting
First Posted : July 12, 2017
Last Update Posted : September 6, 2018
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

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.


Condition or disease Intervention/treatment Phase
Lupus Nephritis Drug: Artesunate Other: placebo Phase 4

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Artesunate Plus Standard of Care in Active Lupus Nephritis: Pilot Study
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: low dose Art
25mg bid Artesunate and standard of care was given to patients
Drug: Artesunate
Artesunate was produced by pharmaceutical factory for research specifically
Other Name: Art

Experimental: high dose Art
50mg bid Artesunate and standard of care was given to patients
Drug: Artesunate
Artesunate was produced by pharmaceutical factory for research specifically
Other Name: Art

Placebo Comparator: placebo
Placebo and standard of care was given to patients
Other: placebo
placebo was produced by pharmaceutical factory for research specifically




Primary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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, Inability or unwillingness to provide written informed consent, 2, eGFR<30ml/min/1.73m2, 3, Subjects who have previously failed both MMF (or other forms of mycophenolate) induction therapies, 4, 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, 5, 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), 6, Have acute or chronic infection requiring management based on the investigator's opinion, 7, Pregnant, nursing or under unreliable contraceptive method, 8, 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, 9, Have a history of kidney transplant or a plan of kidney transplant, 10, 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), 11, 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, 12, Have a history of malignant neoplasm within the last 5 years, except for adequately treated carcinoma in situ of the uterine cervix, 13, Recruited by other trial and/or use study agent within 4 weeks.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03214731


Contacts
Contact: Xueqing Yu, MD, Phd 13802793488 yuxq@mail.sysu.edu.cn
Contact: Wei Chen, MD, Phd 13924150966 vvchen66@qq.com

Locations
China, Guangdong
The 1st Affiliated Hospital, Sun Yet-sen University
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Sun Yat-sen University
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

Responsible Party: Xue Qing Yu, Professor of Medicine Director, Institute of Nephrology The First Affiliated Hospital Sun Yat-Sen University, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03214731     History of Changes
Other Study ID Numbers: AURORA
First Posted: July 12, 2017    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xue Qing Yu, Sun Yat-sen University:
artesunate

Additional relevant MeSH terms:
Nephritis
Lupus Nephritis
Lupus Erythematosus, Systemic
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Artesunate
Artemisinins
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials