Diabetic Kidney DiseasePhase 2RACE IINCT00672451

Rhubarb and Angiotensin Converting Enzyme Inhibitor

A Phase 2 study testing rhubarb extract in people with Diabetic Kidney Disease, run by Wake Forest University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetic Kidney Disease
What is being tested?: rhubarb extract
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 8 participants
Where: 1 siteUnited States
Study dates: Jan 2008to May 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Wake Forest University Heath Sciences
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

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.

Read the 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.

Conditions: Diabetic Kidney Disease
Being tested: rhubarb extract, placebo
Keywords: diabetic kidney disease, albuminuria
Medical subject headings: Diabetic Nephropathies, Albuminuria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

rhubarb extractDietary supplement
titrate rhubarb extract titrated up to 6grams daily by mouth
placeboDietary supplement
placebo titrated up to 6 pills daily as patient tolerates

Study groups in NCT00672451
Study group	Role	What they receive
rhubarb extract	Experimental	will receive rhubarb extract Receives: Dietary Supplement: rhubarb extract
placebo	Placebo comparator	receive placebo Receives: Dietary Supplement: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Albumin Concentration in Urine
Measured: up to 15 months

Secondary outcomes (1)

Rate of Decline of GFR
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008May 2009

First posted6 May 2008 (estimated)
Study startJan 2008
Primary completionMay 2009
Study completionMay 2009

Why it stopped: unable to meet recruitment goal

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00672451
Sponsor's protocol ID: IRB00000616
Other IDs: 1R21AT002367-01A2
Acronym: RACE II
Status last verified: Nov 2018
First submitted: 2 May 2008
Last updated: 13 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Family Investigation of Nephropathy and Diabetes (F.I.N.D.)
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Pentoxifylline in Diabetic Kidney Disease
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A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
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Not yet recruitingObservational study
Relationship Between Insulin Dose and Complications in Type 1 Diabetes
Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD)

All Diabetic Kidney Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Rhubarb and Angiotensin Converting Enzyme Inhibitor
ClinicalTrials.gov ID: NCT00672451
Acronym / sponsor ID: RACE II / IRB00000616
Conditions: Diabetic Kidney Disease
Keywords: diabetic kidney disease, albuminuria
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: unable to meet recruitment goal
Enrolment: 8 participants (actual)
Lead sponsor: Wake Forest UniversityUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Study start: Jan 2008
Primary completion: May 2009 (actual)
Study completion: May 2009 (actual)
First posted: 6 May 2008 (estimated)
Results: Posted 15 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
rhubarb extract	Experimental	Dietary Supplement: rhubarb extractwill receive rhubarb extract
placebo	Placebo comparator	Dietary Supplement: placeboreceive placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (18 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
rhubarb extracttitrate rhubarb extract titrated up to 6grams daily by mouth	Dietary supplement	rhubarb extract
placeboplacebo titrated up to 6 pills daily as patient tolerates	Dietary supplement	placebo

Primary outcome

Albumin Concentration in Urine
Time frame: up to 15 months

1 secondary outcome

Rate of Decline of GFR
Time frame: 2 years

Results and safety

Results posted to the registry on 15 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rhubarb Extract	1	1
Placebo	2	2

Primary outcome: Albumin Concentration in Urine

Time frame: up to 15 months. Mean (Standard Deviation). Unit: mg/dL

Measure	Rhubarb Extract n = 1	Placebo n = 1
Value	.3 (0)	7.9 (0)

Population analysed: Data not collected in all participants of the placebo group.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: up to 2 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rhubarb Extract	0 of 1 (0%)	0 of 1 (0%)	0 of 1
Placebo	0 of 2 (0%)	0 of 2 (0%)	0 of 2

Limitations and caveats (from the sponsor): This study was terminated for lack of accrual. The rate of decline of GFR was not calculated as the values needed were not collected.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diabetic Kidney Disease

Not yet recruitingObservational study
Beta-2-Trace Protein in Diabetic Nephropathy
Diabetic Nephropathy Type 2, Type 2 Diabetes Mellitus
Active, not recruitingObservational study
Family Investigation of Nephropathy and Diabetes (F.I.N.D.)
Diabetic Nephropathy, Diabetes Mellitus
Active, not recruitingPhase 4
Pentoxifylline in Diabetic Kidney Disease
Diabetic Kidney Disease
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Not yet recruitingObservational study
Relationship Between Insulin Dose and Complications in Type 1 Diabetes
Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John Burkart, MD principal investigator

Wake Forest University Health Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rhubarb extract in people with Diabetic Kidney Disease, run by Wake Forest University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Albumin Concentration in Urine (time frame: up to 15 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00672451.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2018.