- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00672451
Rhubarb and Angiotensin Converting Enzyme Inhibitor (RACE II)
Study Overview
Status
Conditions
Intervention / Treatment
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 pressure and blood sugar control as well as other possible interventions. Experimental studies in chronic kidney disease (CKD) patients in China has suggested that rhubarb extract when used alone is equivalent to the protection afforded by ACEI. Furthermore when used in combination with ACEI, the renoprotective effect of rhubarb appears to be additive.
Rhubarb extract is a chinese herbal preparation that is used extensively in china and other asian countries to treat constipation and CKD. Its mechanism of action in preventing progression of CKD is uncertain but perhaps related to TGF beta and TNF alpha inhibition.
The specific aim is to determine the combined effect of rhubarb plus enalapril slowing the rate of decline of CKD (using Iothalamate GFRs) in patients in diabetes. A secondary aim would be to measure serum TGF beta concentrations over time and see if any observed decrease in the rate of decline of CKD is related to changes in TGF beta levels.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Heath Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo
receive placebo
|
placebo titrated up to 6 pills daily as patient tolerates
|
Experimental: rhubarb extract
will receive rhubarb extract
|
titrate rhubarb extract titrated up to 6grams daily by mouth
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Albumin Concentration in Urine
Time Frame: up to 15 months
|
up to 15 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of Decline of GFR
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John Burkart, MD, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00000616
- 1R21AT002367-01A2 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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