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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2006 by Peking University. Recruitment status was Active, not recruiting

First Received on September 19, 2006. Last Updated on September 21, 2006 History of Changes

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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment

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 ClinicalTrials.gov Identifier (NCT Number):

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.

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

Additional relevant MeSH terms:

Glomerulonephritis
Glomerulonephritis, IGA
Nephritis
Kidney Diseases
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Prednisone
Cilazapril
Losartan
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on February 09, 2012