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Search / Trial NCT00672451

Rhubarb and Angiotensin Converting Enzyme Inhibitor

Launched by WAKE FOREST UNIVERSITY · May 5, 2008

Trial Information

Current as of May 16, 2025

Terminated

Keywords

Diabetic Kidney Disease Albuminuria

ClinConnect Summary

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 preparatio...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Male or female patients \>18 years
  • 2. 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.
  • 3. Proteinuria ≥ 0.5 g/day
  • 4. Ability to sign consent form
  • Exclusion Criteria:
  • 1. Pre study GFR (see section 10.7) \< 20 ml/min
  • 2. Renal disease of etiologies other than diabetes
  • 3. Uncontrolled hypertension (Systolic BP \>180 mmHg and Diastolic BP \>110mm Hg)
  • 4. Patients with history of kidney stones in past 10 years
  • 5. Patients with active chronic liver disease (Liver enzymes ALT, AST \>2.5 times normal)
  • 6. 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)
  • 7. 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
  • 8. 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)
  • 9. Patients with significant unstable cardiovascular disease (NYHA class III and IV)
  • 10. Patients with active malignancy
  • 11. Uncontrolled infections.
  • 12. Patients with a known sensitivity to the study medications (including enalapril)
  • 13. Patients on angiotensin II receptor blockers (ARBs)
  • 14. Microscopic or macroscopic hematuria (to rule out kidney disease other than diabetic nephropathy)
  • 15. Patients on any herbal supplements unwilling to discontinue them
  • 16. Severe malnutrition (serum albumin \<2.6mg/dL)
  • 17. Hyperkalemia at baseline, defined as serum potassium ≥ 5.5 mg/dL
  • 18. Iodine allergy.

About Wake Forest University

Wake Forest University is a leading academic institution known for its commitment to innovative research and excellence in education. The university's clinical trial sponsor arm focuses on advancing medical knowledge and improving patient care through rigorous clinical investigations. With a multidisciplinary team of experienced researchers and healthcare professionals, Wake Forest University engages in a wide range of clinical studies that span various therapeutic areas. The institution emphasizes ethical practices, participant safety, and collaboration with industry and regulatory bodies to ensure the integrity and success of its clinical trials. Through its robust research infrastructure, Wake Forest University aims to translate scientific discoveries into effective clinical solutions, ultimately enhancing health outcomes for diverse populations.

Locations

Winston Salem, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

John Burkart, MD

Principal Investigator

Wake Forest University Health Sciences

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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