NCT05797038

Brief Summary

We propose hyperspectral imaging analysis as a method to identify the efficacy of hormone-tacrolimus therapy for PMN, and to classify sensitive and insensitive patients treated with hormone-tacrolimus regimen. A variety of machine learning models were used to prove that hyperspectral imaging technology could assist patients in selecting the optimal treatment plan, and further explore the predictive indicators of PMN treatment effect.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 4, 2023

Completed
21 days until next milestone

Study Start

First participant enrolled

April 25, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

April 4, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

March 18, 2023

Last Update Submit

March 31, 2023

Conditions

Idiopathic Membranous NephropathyTacrolimusHyperspectral Imaging

Outcome Measures

Primary Outcomes (1)

  • Microhyperspectral image of a transrenal specimen

    Microhyperspectral image of a pathological section of the kidney

    2023.4-2023.12

Study Arms (2)

TAC group in remission

The patients with idiopathic membranous nephropathy were divided into two groups, the remission group and the non-remission group after the application of tacrolimus. The renal pathological sections of the two groups were observed by microhyperspectral imaging system, and the differences in the spectra of the two groups were analyzed.

Drug: Tacrolimus for the treatment of IMN

TAC group without remission

The patients with idiopathic membranous nephropathy were divided into two groups, the remission group and the non-remission group after the application of tacrolimus. The renal pathological sections of the two groups were observed by microhyperspectral imaging system, and the differences in the spectra of the two groups were analyzed.

Drug: Tacrolimus for the treatment of IMN

Interventions

Tacrolimus for the treatment of IMNDRUG

Remission after tacrolimus treatment of IMN

TAC group in remissionTAC group without remission

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with clinical manifestations of massive albuminuria and confirmed by renal biopsy as idiopathic membranous nephropathy.

You may qualify if:

  • Over 18 years old;
  • Patients with idiopathic membranous nephropathy confirmed by renal biopsy;
  • Had not received hormone and/or immunosuppressive therapy before renal biopsy;
  • Complete clinical data, all signed the "Admission Certificate of Qianfoshan Hospital of Shandong Province", and agreed to use relevant medical information, biological specimen examination and examination results for scientific research.

You may not qualify if:

  • There are factors causing secondary membranous nephropathy, such as immune diseases (systemic lupus erythematosus), tumors/infections (viral hepatitis), drugs or poisons, etc;
  • Severe infection: fever, cough and expectoration, sore throat, abdominal pain, diarrhea, carbuncle and furuncle and other clinical manifestations of skin and soft tissue infection, blood routine white blood cell count beyond the normal range (10×109/L);
  • Severe cardiovascular disease: including chronic heart failure grade 3 or above and various arrhythmias;
  • Infectious diseases: active hepatitis, AIDS, syphilis, etc. ;
  • Tumor evidence: it has been found that there is a certain tumor or clinical manifestations, tumor markers, etc.,suggesting the possibility of tumor;
  • Patients with follow-up time less than 6 months, incomplete data or missed diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Renal aspiration biopsy pathology

MeSH Terms

Conditions

Glomerulonephritis, Membranous

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Central Study Contacts

Wang Zongsong

CONTACT

18660190175wzsong3@163.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Qianfo Mountain Hospital of Shandong Province

Study Record Dates

First Submitted

March 18, 2023

First Posted

April 4, 2023

Study Start

April 25, 2023

Primary Completion

July 20, 2023

Study Completion

December 30, 2023

Last Updated

April 4, 2023

Record last verified: 2023-03