NCT01539902

Brief Summary

The efficacy measure of hUC-MSC in the treatment of proliferative lupus nephritis on remission of lupus nephritis (combined partial and complete remission) in terms of stabilization and improvement in renal function.

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
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_2

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

Study Start

First participant enrolled

February 1, 2012

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 28, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

March 6, 2012

Status Verified

March 1, 2012

Enrollment Period

1.1 years

First QC Date

February 22, 2012

Last Update Submit

March 5, 2012

Conditions

Lupus Nephritis

Keywords

MSC for the treatment of Lupus Nephritis

Outcome Measures

Primary Outcomes (1)

  • Efficacy and Safety

    The efficacy measure is remission of nephritis (combined partial and complete remission) at 6 months defined as * Stabilization or improvement in renal function and * Urinary RBC of less than 10 per HPF and * Reduction of proteinuria to less than 3 g/day if baseline proteinuria was more than 3 g/day and at least a 50% reduction in proteinuria, or to less than 1 g/day if the baseline proteinuria was in the subnephrotic range.

    6 months

Study Arms (2)

Human Umbilical Cord derived MSCs

EXPERIMENTAL
Biological: Human Umbilical Cord derived MSCs

Cyclophosphamide

PLACEBO COMPARATOR
Drug: Cyclophosphamide

Interventions

Human Umbilical Cord derived MSCsBIOLOGICAL

Human Umbilical Cord derived MSCs treatment for lupus nephritis via infusion

Also known as: Allogeneic stem cells derived from umbilical cord
Human Umbilical Cord derived MSCs
CyclophosphamideDRUG

Cyclophosphamide based immunosuppressive agent for treatment for lupus nephritis

Also known as: Immunosupressive agent
Cyclophosphamide

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male or non-pregnant females age 16 to 65 years inclusive.
  • Written informed consent obtained from patient or parents/guardian.
  • Patients with SLE fulfilling American Rheumatism Association criteria and SLEDAI score\>8 or BILAG score A/B.
  • Patients with newly diagnosed World Health Organization (WHO) Class III or IV Lupus Nephritis

You may not qualify if:

  • Patients with any of the following are not eligible for enrollment into the study:
  • Pregnant or nursing woman or women of childbearing potential except if post-menopausal, surgically sterile or using accepted method(s) of birth control or having negative pregnancy test.
  • Participation in any research in which the patient received an investigational product within 30 days preceding the screening phase of this study.
  • Those persons directly involved in the conduct of the study.
  • Serum creatinine more than 250 µmol/L.
  • White blood cell (WBC) count of less than 3.5 X 109/L.
  • Active peptic ulcer disease.
  • Active systemic infection.
  • History of alcohol or substance abuse.
  • History of malignancy within previous 5 years.
  • Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital & SLE Research Centre, Kunming Medical University, Kunming China

Kunming, Yunan, 650000, China

RECRUITING

Related Publications (1)

  • Deng D, Zhang P, Guo Y, Lim TO. A randomised double-blind, placebo-controlled trial of allogeneic umbilical cord-derived mesenchymal stem cell for lupus nephritis. Ann Rheum Dis. 2017 Aug;76(8):1436-1439. doi: 10.1136/annrheumdis-2017-211073. Epub 2017 May 6.

    PMID: 28478399DERIVED

MeSH Terms

Conditions

Lupus Nephritis

Interventions

Cyclophosphamide

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 Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2012

First Posted

February 28, 2012

Study Start

February 1, 2012

Primary Completion

March 1, 2013

Study Completion

May 1, 2013

Last Updated

March 6, 2012

Record last verified: 2012-03

Locations

CN(1)