Status:
TERMINATED
Rhubarb and Angiotensin Converting Enzyme Inhibitor
Lead Sponsor:
Wake Forest University
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Diabetic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Rhubarb extract is a chinese herbal preparation that is used in china and other asian countries to treat constipation and chronic kidney disease. Use of angiotensin converting enzyme inhibitors (ACEI)...
Detailed Description
Use of angiotensin converting enzyme inhibitors (ACEI) in diabetic nephropathy has been shown to be beneficial in slowing progression of disease. This would include use of ACEI, aggressive blood press...
Eligibility Criteria
Inclusion
- Male or female patients \>18 years
- Patients with diabetic nephropathy (history of type 1 or type 2 diabetes for \> 7 years, no other cause for proteinuria listed in their medical chart). This is the definition used in most peer-reviewed trials44,45 of diabetic nephropathy. We do recognize that their proteinuria could be due to some other concomitant kidney disease but the only way to confirm that is to do a kidney biopsy which is not clinically justified.
- Proteinuria ≥ 0.5 g/day
- Ability to sign consent form
Exclusion
- Pre study GFR (see section 10.7) \< 20 ml/min
- Renal disease of etiologies other than diabetes
- Uncontrolled hypertension (Systolic BP \>180 mmHg and Diastolic BP \>110mm Hg)
- Patients with history of kidney stones in past 10 years
- Patients with active chronic liver disease (Liver enzymes ALT, AST \>2.5 times normal)
- Patients with primary small bowel disease with malabsorption, blind loop syndrome, or jejunoileal bypass surgery (may cause unabsorbed fatty acids to combine with calcium which in turn causes too much absorption of oxalate)
- Patients with current alcohol, illicit drug use or any other condition (eg. Psychiatry disorder) that in the opinion of the investigator may interfere with the patient's ability to comply with the study
- Pregnant women or women of child bearing potential who are unwilling to use an adequate form of contraceptive during the course of the study (ACEI may be fetotoxic)
- Patients with significant unstable cardiovascular disease (NYHA class III and IV)
- Patients with active malignancy
- Uncontrolled infections.
- Patients with a known sensitivity to the study medications (including enalapril)
- Patients on angiotensin II receptor blockers (ARBs)
- Microscopic or macroscopic hematuria (to rule out kidney disease other than diabetic nephropathy)
- Patients on any herbal supplements unwilling to discontinue them
- Severe malnutrition (serum albumin \<2.6mg/dL)
- Hyperkalemia at baseline, defined as serum potassium ≥ 5.5 mg/dL
- Iodine allergy.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00672451
Start Date
January 1 2008
End Date
May 1 2009
Last Update
December 13 2018
Active Locations (1)
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1
Wake Forest University Heath Sciences
Winston-Salem, North Carolina, United States, 27157