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

Primary Purpose

Lupus Nephritis

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Artesunate

placebo

About this trial

This is an interventional treatment trial for Lupus Nephritis focused on measuring artesunate

Eligibility Criteria

14 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

The 1st Affiliated Hospital, Sun Yet-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

low dose Art

high dose Art

placebo

Arm Description

25mg bid Artesunate and standard of care was given to patients

50mg bid Artesunate and standard of care was given to patients

Placebo and standard of care was given to patients

Outcomes

Primary Outcome Measures

Remission

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT03214731

First Posted

July 8, 2017

Last Updated

September 21, 2021

Sponsor

Sun Yat-sen University

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

1. Study Identification

Unique Protocol Identification Number

NCT03214731

Brief Title

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

Acronym

AURORA

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

January 16, 2019 (Actual)

Primary Completion Date

September 30, 2022 (Anticipated)

Study Completion Date

September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lupus Nephritis

Keywords

artesunate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

low dose Art

Arm Type

Experimental

Arm Description

25mg bid Artesunate and standard of care was given to patients

Arm Title

high dose Art

Arm Type

Experimental

Arm Description

50mg bid Artesunate and standard of care was given to patients

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

Placebo and standard of care was given to patients

Intervention Type

Drug

Intervention Name(s)

Artesunate

Other Intervention Name(s)

Art

Intervention Description

Artesunate was produced by pharmaceutical factory for research specifically

Intervention Type

Other

Intervention Name(s)

placebo

Intervention Description

placebo was produced by pharmaceutical factory for research specifically

Primary Outcome Measure Information:

Title

Remission

Description

Time Frame

6 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xueqing Yu, MD, Phd

Phone

13802793488

yuxq@mail.sysu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Wei Chen, MD, Phd

Phone

13924150966

vvchen66@qq.com

Facility Information:

Facility Name

The 1st Affiliated Hospital, Sun Yet-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510080

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xueqing Yu, M.D. & Ph.D.

yuxq@mail.sysu.edu.cn

First Name & Middle Initial & Last Name & Degree

Xueqing Yu, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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