NCT02712697

Brief Summary

The present study was designed to identify the efficacy and safety of Integrative Medicine by joint oral steroid medicine on liver-kidney yin deficiency, severe IgA nephropathy. Furthermore, search for potential diagnostic predictor in IgA Nephropathy by Proteomics and Metabolomics.

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
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

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

November 17, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 18, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 18, 2016

Status Verified

November 1, 2015

Enrollment Period

1.5 years

First QC Date

November 17, 2015

Last Update Submit

March 17, 2016

Conditions

Primary IgA Nephropathy

Keywords

liver-kidney yin deficiency syndromeprimary severe IgA nephropathyLee's grade Ⅲ

Outcome Measures

Primary Outcomes (1)

  • Glomerular filtration rate

    changes from Baseline to 2, 4, 12, 24,36 and 48 weeks

Secondary Outcomes (4)

  • 24-hour urinary protein excretion

    changes from Baseline to 2, 4, 12, 24,36 and 48 weeks

  • serum creatinine

    changes from Baseline to 2, 4, 12, 24,36 and 48 weeks

  • serum Lipid

    Half-yearly

  • TCM syndrome score

    changes from Baseline to 2, 4, 12, 24,36 and 48 weeks

Study Arms (2)

WM Group

EXPERIMENTAL

Shentong Granules, two packs, bid, P.O., 48weeks; Prednisone, 0.5-1mg/kg.d, P.O., eight to twelve weeks; then reduced to 30mg by reduce 5mg every two weeks; followed by the monthly reduction of 5mg, about 9-12 months

Drug: WM (Shentong Granules)Drug: Hormone (prednisone)

Hormone Group

PLACEBO COMPARATOR

Placebo ; Prednisone, 0.5-1mg/kg.d, P.O., eight to twelve weeks; then reduced to 30mg by reduce 5mg every two weeks; followed by the monthly reduction of 5mg, about 9-12 months

Drug: Hormone (prednisone)

Interventions

WM (Shentong Granules)DRUG

Shentong Granules with Prednisone

Also known as: Shentong Granules
WM Group
Hormone (prednisone)DRUG

Oral prednisone

Also known as: prednisone
Hormone GroupWM Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The primary IgAN was confirmed by renal biopsy and clinical examination, and the pathological manifestations were Lee's grade and above;
  • TCM is liver kidney yin deficiency syndrome;
  • age 18-70 years old, sex, nationality is not limited;
  • CKD phase 2-4 （89 ml/min\>eGFR（EPI Formula）\>15ml/min/1.73m2）;
  • hour urinary protein≥1g.

You may not qualify if:

  • It had received immunosuppressive drugs and cytotoxic therapy within the past 3 months more than 4 weeks;
  • It had received corticosteroids (prednisone or prednisolone) within the past 3 months more than 20mg/d for more than up to 4 weeks;
  • Acute or progressive glomerulonephritis patients;
  • Severe complications threat to life, such as severe infection;
  • Active hepatitis B and liver function test sustained abnormal;
  • Patients with malignant tumor or have a history of cancer, HIV infection, history of mental illness, acute central nervous system diseases, severe gastrointestinal diseases, prohibition of the use of hormone;
  • Abnormal glucose metabolism, fasting blood glucose over 6.2mmol/L;
  • Gravid or lactation woman;
  • Other clinical trials are being studied;
  • Merger with other serious disease and dysfunction of the organ.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nephrology,Longhua Hospital

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

HormonesPrednisone

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Hormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Central Study Contacts

Yueyi Deng, MD.

CONTACT

+86-021-64385700-3226dengyueyi@medmail.com.cn

Wanjia Chen, MS.

CONTACT

+86-021-64385700-3222wdgzkj@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2015

First Posted

March 18, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 18, 2016

Record last verified: 2015-11

Locations

CN(1)