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

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ClinicalTrials.gov Identifier: NCT00378443
Recruitment Status : Unknown
Verified September 2006 by Peking University.
Recruitment status was:  Active, not recruiting
First Posted : September 20, 2006
Last Update Posted : September 22, 2006
Sponsor:
Information provided by:
Peking University

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.

Condition or disease Intervention/treatment Phase
Glomerulonephritis, IGA Drug: prednisone + Inhibace/Cozaar Drug: Inhibace/Cozaar Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2006
Study Completion Date : June 2007

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U.S. FDA Resources




Primary Outcome Measures :
  1. Serum creatinine
  2. 24 hour urinary protein excretion

Secondary Outcome Measures :
  1. Urinalysis
  2. serum urea
  3. serum albumin


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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. underwent renal biopsy within 1 year before start fo trial;
  2. 24 hour urinary protein excretion ranged between 1 to 7 g/d;
  3. eGFR, evaluated by MDRD formula, should be higher than 30 ml/min

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00378443


Sponsors and Collaborators
Peking University
Investigators
Principal Investigator: Hong Zhang, MD Renal Division, Peking University First Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00378443     History of Changes
Other Study ID Numbers: [2006]022
First Posted: September 20, 2006    Key Record Dates
Last Update Posted: September 22, 2006
Last Verified: September 2006

Additional relevant MeSH terms:
Glomerulonephritis
Glomerulonephritis, IGA
Nephritis
Kidney Diseases
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Prednisone
Losartan
Cilazapril
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors