Angiotensin II Antagonism of TGF-Beta 1
This study has been completed.
Sponsor:
Providence Health & Services
Collaborator:
AstraZeneca
Information provided by:
Providence Health & Services
ClinicalTrials.gov Identifier:
NCT00320970
First received: April 28, 2006
Last updated: August 1, 2007
Last verified: March 2006
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Purpose
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) in the United States and in the developed world is diabetic nephropathy. Currently, more than half the United States ESRD population has diabetes. More effective therapies to prevent and treat diabetic nephropathy are urgently needed. One way to increase therapeutic effectiveness is to refine treatment targets based on improved understanding of how treatments modulate disease processes. The purpose of this study is to determine whether a treatment for diabetic nephropathy, the angiotensin receptor blocker candesartan, modifies mediators of kidney injury independent of blood pressure and the relationships to drug dose.
| Condition | Intervention |
|---|---|
|
Diabetic Nephropathy Hypertension |
Drug: Candesartan |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Angiotensin II Antagonism of TGF-Beta 1: A Candesartan Dose - TGF-Beta 1 Response Relationship Study |
Resource links provided by NLM:
Further study details as provided by Providence Health & Services:
Primary Outcome Measures:
- Blood pressure
- Urinary TGF-Beta 1
- Serum angiotensin II
- Urinary albumin
- Urinary carboxymethyllysine
| Estimated Enrollment: | 36 |
| Study Start Date: | August 2002 |
| Estimated Study Completion Date: | September 2004 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00320970
Locations
| United States, Washington | |
| Providence Medical Research Center | |
| Spokane, Washington, United States, 99204 | |
Sponsors and Collaborators
Providence Health & Services
AstraZeneca
Investigators
| Principal Investigator: | Katherine R. Tuttle, MD,FASN,FACP | Providence Medical Research Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00320970 History of Changes |
| Other Study ID Numbers: | HI831 |
| Study First Received: | April 28, 2006 |
| Last Updated: | August 1, 2007 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Providence Health & Services:
|
TGF-Beta 1 Angiotensin II Advanced glycation end products |
Additional relevant MeSH terms:
|
Diabetic Nephropathies Hypertension Kidney Diseases Urologic Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Vascular Diseases Cardiovascular Diseases Angiotensin II |
Candesartan Candesartan cilexetil Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013