Clinical trial
Effect of Renin-angiotensin-system Blockade on Urinary Free Light Chains in Patients With Type 2 Diabetes Mellitus
Name
258683
Description
The purpose of this study is to study the effect of blocking the renin angiotensin system on urinary free light chain excretion as compared to urine microalbumin creatinine ratio in subjects with type 2 diabetes. The long term goal is to assess urinary free-light chains as a biomarker of earlier detection of kidney function impairment in subjects with diabetes mellitus.
Trial arms
Trial start
2012-01-01
Estimated PCD
2019-12-01
Trial end
2019-12-01
Status
Completed
Phase
Early phase I
Treatment
amlodipine, hydralazine, terazosin or hydrochlorothiazide
In the washout period, the Ace Inh or ARB classes of medicine(s) that are part of the patient's antihypertensive regimen will be discontinued. The patient will be started on alternative therapy with medications that are approved by the Food and Drug Administration for treatment of high blood pressure (such as amlodipine, hydralazine, terazosin or Hydrochlorothiazide) for control of their blood pressure.
Arms:
Washout Period for 30 days
Other names:
Norvasc
Size
28
Primary endpoint
Change in Urine Microalbumin Creatinine Ratio
Visit 1 (Baseline), Visit 3 (Day 60)
Eligibility criteria
Inclusion Criteria:
* Type 2 Diabetes
* Hypertension
* Estimated glomerular filtration rate (eGFR) \> 30 ml/min
* Use of Ace Inh and ARB for control of blood pressure who are willing to be placed on alternate drug(s) in the washout period for blood pressure control
Exclusion Criteria:
* Pregnancy
* Patients with chronic kidney disease stage with eGFR \< 30 ml/min (CKD stage IV and V)
* Nephrotic range proteinuria (urinary protein \> 3.5 gm/day)
* History or renal transplantation
* History of multiple myeloma
* Known history of hypersensitivity reaction or intolerability to Ace Inh or ARB.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 28, 'type': 'ACTUAL'}}
Updated at
2023-08-21
1 organization
Organization
Tulane University School of Medicine