NCT05495893

Brief Summary

A prospective, randomized, multicenter, open-label, parallel-arm Study to compare effectiveness of mycophenolate mofetil versus cyclophosphamide in the Induction Therapy of pediatric patients with Active Proliferative Lupus Nephritis in Chinese population

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
224

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2022

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

July 25, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 10, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

August 10, 2022

Status Verified

August 1, 2022

Enrollment Period

2.9 years

First QC Date

July 25, 2022

Last Update Submit

August 8, 2022

Conditions

Mycophenolate MofetilCyclophosphamideLupus Nephritis

Outcome Measures

Primary Outcomes (1)

  • Effective rate of LN treatment

    complete remission and partial remission

    6 months

Secondary Outcomes (7)

  • complete remission time

    6 months

  • Incidence of LN treatment failure

    6 months

  • Incidence of creatinine doubling

    6 months

  • LN recurrence rate

    6 months

  • SLE recurrence rate

    6 months

  • +2 more secondary outcomes

Study Arms (2)

Cyclophosphamide

EXPERIMENTAL

Cyclophosphamide for injection, 750mg/m2 each time, 1g at most, once a month for 6 consecutive months. Steroids : intravenous methylprednisolone, 15\~30mg/kg · day, maximum 1000mg/day, 3 consecutive days a week for 2 weeks; during the interval of methylprednisolone pulse therapy and after:prednisone tablets 2mg/kg · day with a maximum dose 60mg / day

Drug: Cyclophosphamide

Mycophenolate mofetil

EXPERIMENTAL

Mycophenolate mofetil, tablets, 30-40mg/ (kg · day), BID, the maximum amount is no more than 2g/d. Steroids : intravenous methylprednisolone, 15\~30mg/kg · day, maximum 1000mg/day, 3 consecutive days a week for 2 weeks; during the interval of methylprednisolone pulse therapy and after:prednisone tablets 2mg/kg · day with a maximum dose 60mg / day

Drug: Mycophenolate Mofetil

Interventions

CyclophosphamideDRUG

The patients will be divided into two groups randomly. Cyclophosphamide for injection, 750mg/m2 each time, 1g at most, once a month for 6 consecutive months. Steroids : intravenous methylprednisolone, 15\~30mg/kg · day, maximum 1000mg/day, 3 consecutive days a week for 2 weeks; during the interval of methylprednisolone pulse therapy and after:prednisone tablets 2mg/kg · day with a maximum dose 60mg / day. The duration of induction therapy: 6 months.

Cyclophosphamide
Mycophenolate MofetilDRUG

The patients will be divided into two groups randomly. Mycophenolate mofetil, tablets, 30-40mg/ (kg · day), BID, the maximum amount is no more than 2g/d. Steroids : intravenous methylprednisolone, 15\~30mg/kg · day, maximum 1000mg/day, 3 consecutive days a week for 2 weeks; during the interval of methylprednisolone pulse therapy and after:prednisone tablets 2mg/kg · day with a maximum dose 60mg / day. The duration of induction therapy: 6 months.

Mycophenolate mofetil

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 5-17 years old;
  • SLE patients who meet the updated 2019 eular/acr SLE classification criteria or 2012 SLICC diagnostic criteria;
  • According to the revised International Society of Nephrology / Society of renal pathology (isn/rps) classification in 2018, it conforms to active proliferative ln type III or IV, with or without type V;
  • Glomerular filtration rate EGFR ≥ 60 ml/min/1.73 m2;
  • hour urinary protein quantitation ≥ 25mg/kg, or urinary protein / creatinine 1.0mg/mg;
  • Blood routine WBC count ≥ 3.0\*10\^9/l, lymphocyte ≥ 0.5\*10\^9/l before enrollment;
  • No immunosuppressants such as cyclophosphamide, mycophenolate mofetil, cyclosporine A, tacrolimus, azathioprine, methotrexate, or biological agents such as rituximab, baileyoumab, and etaxel were used before enrollment.

You may not qualify if:

  • A known history of primary immunodeficiency, splenectomy, or any potential disease that makes participants vulnerable to infection;
  • Evidence of hepatitis C, active hepatitis B, HIV infection, tuberculosis infection, severe fungal infection, or other serious infections;
  • Have any history of tumor or cancer;
  • Patients with lupus encephalopathy, diffuse alveolar hemorrhage, severe hemolytic anemia, blood routine platelet count lower than 10.0\*10\^9/l, glomerular filtration rate eGFR \< 60 ml/min/1.73 m2, or patients with other serious complications have unstable vital signs;
  • Have severe gastrointestinal bleeding, pancreatitis, serious heart, liver, blood, endocrine system diseases;
  • Patients who are known to be allergic to mycophenolate mofetil, cyclophosphamide, glucocorticoids or any of the above drugs;
  • Patients who participated in other clinical trials within 3 months before enrollment;
  • The researcher judged that the patient's condition was not suitable for participants in this trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

RECRUITING

MeSH Terms

Conditions

Lupus Nephritis

Interventions

CyclophosphamideMycophenolic Acid

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLupus Erythematosus, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipids

Study Officials

  • Xiaochuan Wu

    The Second Xiangya Hospital, Central South University

    STUDY CHAIR

Central Study Contacts

Xiaochuan Wu

CONTACT

0731-85295259503151@csu.edu.cn

Xiaoyan Li

CONTACT

0731-85295259lixiaoyan001@csu.edu.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Pediatrics

Study Record Dates

First Submitted

July 25, 2022

First Posted

August 10, 2022

Study Start

July 25, 2022

Primary Completion

May 31, 2025

Study Completion

May 31, 2025

Last Updated

August 10, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)