Rhubarb and Angiotensin Converting Enzyme Inhibitor

NCT00672451 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: IRB000006161R21AT002367-01A2
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Kidney Disease

Keywords

diabetic kidney disease; albuminuria

Outcome Measures

Primary Outcomes (1)

• Albumin Concentration in Urine

  up to 15 months

Secondary Outcomes (1)

• Rate of Decline of GFR

  2 years

Study Arms (2)

rhubarb extract

EXPERIMENTAL

will receive rhubarb extract

Dietary Supplement: rhubarb extract

placebo

PLACEBO COMPARATOR

receive placebo

Dietary Supplement: placebo

Interventions

rhubarb extract DIETARY_SUPPLEMENT

titrate rhubarb extract titrated up to 6grams daily by mouth

rhubarb extract

placebo DIETARY_SUPPLEMENT

placebo titrated up to 6 pills daily as patient tolerates

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Wake Forest University Heath Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Diabetic Nephropathies; Albuminuria

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Proteinuria; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This study was terminated for lack of accrual. The rate of decline of GFR was not calculated as the values needed were not collected.

Results Point of Contact

• Title: Dr. John Burkart
• Organization: Wake Forest University Health Sciences

jburkart@wakehealth.edu

33671662958

Study Officials

• John Burkart, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2008
• First Posted: May 6, 2008
• Study Start: January 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: December 13, 2018
• Results First Posted: November 15, 2018

Record last verified: 2018-11

Locations

US (1)