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

Sponsor:	Peking University
Information provided by:	Peking University
ClinicalTrials.gov Identifier:	NCT00378443

Purpose

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.

Condition	Intervention
Glomerulonephritis, IGA	Drug: prednisone + Inhibace/Cozaar Drug: Inhibace/Cozaar

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

Drug Information available for: Prednisone Cilazapril Losartan Losartan potassium

U.S. FDA Resources

Further study details as provided by Peking University:

Primary Outcome Measures:

Serum creatinine
24 hour urinary protein excretion

Secondary Outcome Measures:

Urinalysis
serum urea
serum albumin

Study Start Date:	January 2006
Estimated Study Completion Date:	June 2007

Detailed Description:

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. In the many studies on the treatment of 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, and ACEi/ARB was considered to be the first line therapy. 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.

Eligibility

Ages Eligible for Study:	16 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378443

Sponsors and Collaborators

Peking University

Investigators

Principal Investigator:

Hong Zhang, MD

Renal Division, Peking University First Hospital

More Information

No publications provided by Peking University

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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. Epub 2008 Oct 19.

Study ID Numbers:	[2006]022
Study First Received:	September 19, 2006
Last Updated:	September 21, 2006
ClinicalTrials.gov Identifier:	NCT00378443 History of Changes
Health Authority:	China: Ethics Committee

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Prednisone
Glomerulonephritis
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Urologic Diseases
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Anti-Arrhythmia Agents
Kidney Diseases
Cilazapril

Losartan
Autoimmune Diseases
Immune System Diseases
Antineoplastic Agents, Hormonal
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Glucocorticoids
Pharmacologic Actions
Protease Inhibitors
Angiotensin II Type 1 Receptor Blockers
Nephritis
Glomerulonephritis, IGA

ClinicalTrials.gov processed this record on February 08, 2010