Validity and Security of Reh-acteoside Therapy for Patients of IgA Nephropathy

NCT02662283 | Unknown Phase 2

• 1 other identifier: Usix-IgAN-002
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, randomized, controlled, multi-center clinical trial will evaluate the effect and security of reh-acteoside therapy for patients of IgA nephropathy.

Conditions

IGA Nephropathy

Keywords

IGA Nephropathy; proteinurien; Reh-acteoside; Prednisolone

Outcome Measures

Primary Outcomes (1)

• Remission of proteinuria (complete or partial)

  Complete remission: UPCR (urinary protein creatinine ratio) \<300mg/g, plasma albumin in normal range, and stable serum creatinine level (fluctuation range \<15%)； Partial remission: UPCR decreases more than 50% from baseline, plasma albumin \>30g/L, and stable serum creatinine level (fluctuation range \<15%).

  up to 8 weeks

Secondary Outcomes (2)

• Deterioration of renal function

  up to 8 weeks

• Deacrase of hematuria

  up to 8 weeks

Study Arms (3)

Prednisolone

ACTIVE COMPARATOR

Oral take prednisolone (0.5 mg/kg, qd) for 8 weeks

Drug: Prednisolone

Reh-acteoside

EXPERIMENTAL

Oral take reh-acteoside (0.4g bid) for 8 weeks

Drug: Reh-acteoside

Reh-acteoside+Prednisolone

EXPERIMENTAL

Oral take prednisolone (0.5 mg/kg, qd) and reh-acteoside (0.4g bid) for 8 weeks

Drug: Prednisolone; Drug: Reh-acteoside

Interventions

Prednisolone DRUG

Oral take prednisolone (0.5 mg/kg, qd) for 8 weeks

Prednisolone; Reh-acteoside+Prednisolone

Reh-acteoside DRUG

Oral take and reh-acteoside (0.4g bid) for 8 weeks

Reh-acteoside; Reh-acteoside+Prednisolone

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 14\~70 years, regardless of gender Clinical evaluation and renal biopsy diagnostic for IgA nephropathy. Average urinary protein excretion of 1.0\~3.5g/24h on two successive examinations.
• eGFR ≥ 50 ml/min/1.73 m2 Willingness to sign an informed consent (patients under 18 years old need legal guardian to sign).

You may not qualify if:

• Secondary IgAN such as systemic lupus erythematosus, Henoch-Schonlein purpuric nephritis and hepatitis B -associated nephritis.
• Rapidly progressive nephritic syndrome (crescent formation≥50%). Acute renal failure, including rapidly progressive IgAN. Renal biopsy suggests active pathological change (cellular crescent, loop necrosis, micro-thrombosis formation) Current or recent (within 30 days) exposure to steroids or immunosuppressive therapy (CTX、MMF、CsA、FK506).
• Recent acute hepatitis (in 2 weeks), chronic active hepatitis (hepatitis B or hepatitis C infection), a rise more than 2.5 folds of current ALT, AST or TBil level.
• History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease).
• Any Active systemic infection or history of serious infection within one month. Other major organ system disease (e.g. serious cardiovascular diseases including congestive heart failure , chronic obstructive pulmonary disease, asthma requiring oral steroid treatment or central nervous system diseases).
• Active tuberculosis Malignant hypertension that is difficult to be controlled by oral drugs. Known allergy, contraindication or intolerance to the steroids. Pregnancy or breast feeding at the time of entry or unwillingness to comply with measures for contraception.
• Malignant tumors Excessive drinking or drug abuse Mental aberrations Current or recent (within 30 days) exposure to any other investigational drugs.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Department of Nephrology, 6th Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510655, China

Location

Related Publications (1)

• Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.

  PMID: 38299639 DERIVED

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Zongpei Jiang, M.D. & Ph.D.

  The Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zongpei Jiang, M.D. & Ph.D.

CONTACT

8620-38379727; jx.home@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Sixth Affiliated Hospital of Sun Yat-Sen University

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: January 25, 2016
• Study Start: May 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: February 2, 2016

Record last verified: 2016-02

Locations

CN (1)