Back to results

Rhubarb and Angiotensin Converting Enzyme Inhibitor (RACE II)

Primary Purpose

Diabetic Kidney Disease

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

rhubarb extract

placebo

About this trial

This is an interventional treatment trial for Diabetic Kidney Disease focused on measuring diabetic kidney disease, albuminuria

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Wake Forest University Heath Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

rhubarb extract

placebo

Arm Description

will receive rhubarb extract

receive placebo

Outcomes

Primary Outcome Measures

Albumin Concentration in Urine

Secondary Outcome Measures

Rate of Decline of GFR

Full Information

NCT ID

NCT00672451

First Posted

May 2, 2008

Last Updated

November 15, 2018

Sponsor

Wake Forest University

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

1. Study Identification

Unique Protocol Identification Number

NCT00672451

Brief Title

Rhubarb and Angiotensin Converting Enzyme Inhibitor

Acronym

RACE II

Official Title

Rhubarb and Angiotensin Converting Enzyme Inhibitor

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Terminated

Why Stopped

unable to meet recruitment goal

Study Start Date

January 2008 (undefined)

Primary Completion Date

May 2009 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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) in diabetic kidney disease has been shown to be beneficial in slowing progression. The purpose of this study is to determine the combined effect of rhubarb plus enalapril (an ACEI)in slowing the rate of decline of CKD in people with kidney disease from diabetes.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Kidney Disease

Keywords

diabetic kidney disease, albuminuria

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

rhubarb extract

Arm Type

Experimental

Arm Description

will receive rhubarb extract

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

receive placebo

Intervention Type

Dietary Supplement

Intervention Name(s)

rhubarb extract

Intervention Description

titrate rhubarb extract titrated up to 6grams daily by mouth

Intervention Type

Dietary Supplement

Intervention Name(s)

placebo

Intervention Description

placebo titrated up to 6 pills daily as patient tolerates

Primary Outcome Measure Information:

Title

Albumin Concentration in Urine

Time Frame

up to 15 months

Secondary Outcome Measure Information:

Title

Rate of Decline of GFR

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Burkart, MD

Organizational Affiliation

Wake Forest University Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wake Forest University Heath Sciences

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Rhubarb and Angiotensin Converting Enzyme Inhibitor

We'll reach out to this number within 24 hrs