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

Sponsor

Sun Yat-sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03214731

Collaborator

The First People's Hospital of Yunnan (Other), The First Affiliated Hospital of Nanchang University (Other), General Hospital of Ningxia Medical University (Other), First Affiliated Hospital of Fujian Medical University (Other), Shenzhen Second People's Hospital (Other), The Third Xiangya Hospital of Central South University (Other), Tongji Hospital (Other)

Enrollment

Location

Arms

44.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

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

Study Design

Study Type:

Interventional

Anticipated 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

Actual Study Start Date :

Jan 16, 2019

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

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

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 Names:

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 Names:

Art

Placebo Comparator: placebo

Placebo and standard of care was given to patients

Other: placebo

placebo was produced by pharmaceutical factory for research specifically

Outcome Measures

Primary Outcome Measures

Remission [6 month]
Complete remission: Proteinuria < 0.3g/ 24hr, no active urinary sediment, normal albumin, stable Scr (within 15% fluctuation). 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The 1st Affiliated Hospital, Sun Yet-sen University	Guangzhou	Guangdong	China	510080

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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

Other Study ID Numbers:

AURORA

First Posted:

Jul 12, 2017

Last Update Posted:

Sep 23, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Xue Qing Yu, Professor of Medicine Director, Institute of Nephrology The First Affiliated Hospital Sun Yat-Sen University, Sun Yat-sen University

artesunate

Additional relevant MeSH terms:

Nephritis

Lupus Nephritis

Artesunate

Study Results

No Results Posted as of Sep 23, 2021