Status:
COMPLETED
Angiotensin II Antagonism of TGF-Beta 1
Lead Sponsor:
Providence Health & Services
Collaborating Sponsors:
AstraZeneca
Conditions:
Diabetic Nephropathy
Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Diabetic nephropathy is a frequent microvascular complication that occurs in approximately 40% of patients with either type 1 or type 2 diabetes. The most common cause of end-stage renal disease (ESRD...
Detailed Description
Transforming growth factor-beta 1 (TGF-beta 1) is a potent inducer of extracellular matrix production and of fibrogenesis and has been associated with the occurrence of diabetic micro- and macrovascul...
Eligibility Criteria
Inclusion
- Type 2 diabetes
- Nephropathy (proteinuria \>500 mg/day)
- Chronic Hypertension (as determined by current antihypertensive therapy and/or an average of diastolic blood pressure greater than 90 mmHg or greater or systolic blood pressure of 140 mmHg confirmed on at least two subsequent visits over one week or more).
Exclusion
- Conditions associated with elevated TGF-Beta (e.g. rheumatoid arthritis, cancer, etc.).
- Conditions associated with alterations in serum levels of PIP and/or CITP (liver cirrhosis, osteoporosis, hyperthyroidism, multiple myeloma, osteolytic metastases, and systemic glucocorticoid treatment
- History of Stage III hypertension (diastolic BP \> 110 mmHg or systolic BP \> 180 mmHg) or a history of hypertensive urgency or emergency.
- NYHA Class III or IV heart failure
- Calculated creatinine clearance of less than 30 ml/min or serum creatinine \> 3 mg/dL
- HbA1c \> 10%
- Patients unable to be withdrawn for 2 weeks from AT-II antagonist or ACE- inhibitor therapy
- Blood Pressure \<140/90 is unachievable in the absence of an AT-II antagonist or ACE-inhibitor
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
End Date :
September 1 2004
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00320970
Start Date
August 1 2002
End Date
September 1 2004
Last Update
August 2 2007
Active Locations (1)
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1
Providence Medical Research Center
Spokane, Washington, United States, 99204