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

NCT03214731 | Unknown Phase 4 DMC

• 1 other identifier: AURORA
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Lupus Nephritis

Keywords

artesunate

Outcome Measures

Primary Outcomes (1)

• Remission

  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).

  6 month

Study Arms (3)

low dose Art

EXPERIMENTAL

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

Drug: Artesunate

high dose Art

EXPERIMENTAL

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

Drug: Artesunate

placebo

PLACEBO COMPARATOR

Placebo and standard of care was given to patients

Other: placebo

Interventions

Artesunate DRUG

Artesunate was produced by pharmaceutical factory for research specifically

Also known as: Art

high dose Art; low dose Art

placebo OTHER

placebo was produced by pharmaceutical factory for research specifically

placebo

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• , 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• The First People's Hospital of Yunnan: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• General Hospital of Ningxia Medical University: collaborator
• First Affiliated Hospital of Fujian Medical University: collaborator
• Shenzhen Second People's Hospital: collaborator
• The Third Xiangya Hospital of Central South University: collaborator
• Tongji Hospital: collaborator

Study Sites (1)

The 1st Affiliated Hospital, Sun Yet-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Lupus Nephritis

Interventions

Artesunate; Reproductive Techniques, Assisted

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Sesquiterpenes; Terpenes; Hydrocarbons; Reproductive Techniques; Therapeutics; Investigative Techniques

Central Study Contacts

Xueqing Yu, MD, Phd

CONTACT

13802793488; yuxq@mail.sysu.edu.cn

Wei Chen, MD, Phd

CONTACT

13924150966; vvchen66@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine Director, Institute of Nephrology The First Affiliated Hospital Sun Yat-Sen University

Study Record Dates

• First Submitted: July 8, 2017
• First Posted: July 12, 2017
• Study Start: January 16, 2019
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: September 23, 2021

Record last verified: 2021-09

Locations

CN (1)