ACEi/ARB Alone Versus ACEi/ARB Plus Steroids in the Treatment of Primary IgA Nephropathy, a RCT

NCT00378443 | Unknown

• 1 other identifier: [2006]022
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

IgA nephropathy( IgAN) is the most common primary glomerulonephritis worldwide. Since the etiology of the disease is not clearly understood, no specific therapeutic strategies was defined for IgAN. Both ACEi/ARB and steroid was found to be effective in slowing the rate of disease progression, but the use of steroid was restricted because of its side effects. However, there is no evidence from RCT on the question of whether combined use of steroid with ACEi/ARB can bring more benefit to IgAN patients than ACEi/ARB alone. We therefore undertook a randomized, multicenter study to investigate the efficacy and safety profile of combined use of ACEi/ARB plus steroid compared with ACEi/ARB alone in the treatment of patients with IgAN.

Conditions

Glomerulonephritis, IGA

Outcome Measures

Primary Outcomes (2)

• Serum creatinine

• 24 hour urinary protein excretion

Secondary Outcomes (3)

• Urinalysis

• serum urea

• serum albumin

Interventions

prednisone + Inhibace/Cozaar DRUG

Inhibace/Cozaar DRUG

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• underwent renal biopsy within 1 year before start fo trial;
• hour urinary protein excretion ranged between 1 to 7 g/d;
• eGFR, evaluated by MDRD formula, should be higher than 30 ml/min

You may not qualify if:

• crescentic glomerulonephritis;
• steroid therapy subjected within 1 year before trial;
• malignant hypertension(DBP\> 130 mmHg and/or SBP\> 220mmHg), resistant to anti-hypertensive agents;
• urinary protein excretion decrease below 1 g/l after run-in period;
• Myocardial infarction or cerebrovascular accident in 6 months preceding the trial;
• renovascular disease;
• diabetes mellitus;
• Malignancy, severe liver disease, refractory infection;
• peptic ulcer in active disease phase;
• pregnancy;
• other contraindication to the use of ACEi/ ARB or corticosteroid;
• alcohol abuse or drug addiction

Sponsors & Collaborators

• Peking University: lead

Related Publications (2)

• 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

• Lv J, Zhang H, Chen Y, Li G, Jiang L, Singh AK, Wang H. Combination therapy of prednisone and ACE inhibitor versus ACE-inhibitor therapy alone in patients with IgA nephropathy: a randomized controlled trial. Am J Kidney Dis. 2009 Jan;53(1):26-32. doi: 10.1053/j.ajkd.2008.07.029. Epub 2008 Oct 19.

  PMID: 18930568 DERIVED

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

Prednisone; Cilazapril; Losartan

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)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pyridazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Tetrazoles

Study Officials

• Hong Zhang, MD

  Renal Division, Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 19, 2006
• First Posted: September 20, 2006
• Study Start: January 1, 2006
• Study Completion: June 1, 2007
• Last Updated: September 22, 2006

Record last verified: 2006-09