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Diabetic NephropathyPhase 4BenfoNCT00565318

Benfotiamine in Diabetic Nephropathy

A Phase 4 study testing Benfotiamine in people with Diabetic Nephropathy, run by University Medical Center Groningen at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to investigate the effect of benfotiamine supplementation in patients with diabetic nephropathy, and to determine whether it will slow down the progression to end-stage renal disease (ESRD). Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Diabetic Nephropathy
What is being tested?
Benfotiamine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
86 participants
Where
1 siteNetherlands
Study dates
Dec 2007to Jun 2009
Phase
Phase 4
Are there results?
None posted in the registry

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 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Type 2 diabetes mellitus
  • Patients are on treatment with angiotensin converting enzyme inhibitors (ACEi) and/or angiotensin II antagonists (AIIA) in an unchanged dose for at least 3 months
  • Active diabetic nephropathy as indicated by presence of microalbuminuria (15-300 mg/24 h urine) in at least two samples within 2-6 weeks in advance of inclusion in the trial
  • HbA1c < 8.5%, a higher HbA1c < 9.5% is acceptable if the treating physician and the patient have accepted that striving for lower values is an unreachable goal (patients with high HbA1c values are the ones that one would expect to be benefit most from treatment with benfotiamine)
  • eGFR (estimated by MDRD formula) > 30 ml/min
  • Males and postmenopausal females
  • Written informed consent

Who cannot join

  • Renal impairment by other causes than diabetes
  • Stage of the disease more severe than indicated in Inclusion criteria (macroalbuminuria or renal insufficiency)
  • Severe hypoglycemia during the last 3 months, needing help from another person
  • Severe hepatopathy (laboratory values about three times higher than normal
  • Endocrine disorders, e.g. hyper/hypothyroidism
  • Blood pressure > 160/90 mmHg
Show all 15Show fewer
  • Severe cardiac function disturbances and severe heart rhythm disturbances
  • Neoplasm's (excluding history of treated skin cancer of the type basal cell carcinoma BCC or squamous cell carcinoma SCC)
  • Severe general diseases or mental disorders making the participation in the study impossible
  • Drug abuse
  • Female patients during pregnancy and lactation period and female patients with active menses during the past year
  • Hypersensitivity to benfotiamine
  • HbA1c > 9.5%
  • Use of thiamine containing supplements during the last 3 months
  • Participation in another study within one month before joining the benfotiamine study

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Isala Klinieken Hospital

    Zwolle, 8000 GK

Other trials in Netherlands

About this study

Official title: A Double-Blind Clinical Trial of Benfotiamine Treatment in Diabetic Nephropathy

The purpose of this study is to investigate the effect of benfotiamine supplementation in patients with diabetic nephropathy, and to determine whether it will slow down the progression to end-stage renal disease (ESRD).

Read the detailed description

There is a worldwide increase in prevalence in type 2 diabetes mellitus, which is being paralleled by an increasing number of patients reaching dialysis because of diabetic nephropathy. Much of the fivefold increase in patients receiving dialysis treatment that occurred over the past two decades is attributable to type 2 diabetes and diabetic nephropathy. Diabetes is now the leading cause of end-stage renal disease (ESRD), with more than 40% of all new cases of ESRD occurring in patients with diabetes.

Benfotiamine has been shown to reduce diabetic nephropathy and retinopathy in animal experimental models. We hypothesize that benfothiamine supplementation in patients with diabetic nephropathy will ameliorate the effects of both albuminuria/proteinuria and hyperglycaemia on oxidative stress and advanced glycation end-products (AGEs) accumulation in renal tissue, and thereby decrease inflammatory responses and fibrotic responses, causing slowing down of progression to ESRD as a consequence.

Intervention:

The intervention duration is 12 weeks for each group.

  • Group A: Benfotiamine (300 mg) 3x 1 film coated tablet daily (900 mg daily dose benfotiamine)
  • Group B: Placebo 3x 1 film coated tablet daily
Being tested
Benfotiamine, Placebo
Keywords
Benfotiamine, Diabetes, Nephropathy
Medical subject headings
Diabetic Nephropathies, Diabetes Mellitus, Kidney Diseases

What participants receive

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

  • BenfotiamineDrug

    Also called Milgamma® mono 300, Wörwag Pharma GmbH & Co. KG, A11DA05

    3x 300 mg film coated tablet daily (900 mg per day). Duration: 12 weeks.

  • PlaceboDrug

    Also called Placebo, Wörwag Pharma GmbH & Co. KG

    3x 1 film coated tablet daily. Duration: 12 weeks.

Study groups in NCT00565318
Study groupRoleWhat they receive
AActive comparatorNot described
Receives: Drug: Benfotiamine
BPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Change in urinary excretion of: - Kidney injury molecule-1 (KIM-1) - Albumin

    Measured: 12 weeks

Secondary outcomes (1)

  1. Change in urinary excretion of: β2 microglobulin, macrophage inhibiting factor (MIF), monocyte chemo-attractant protein-1 (MCP-1), and other advanced glycation end-products (AGEs).

    Measured: 12 weeks

Timeline

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

  1. First posted29 Nov 2007 (estimated)
  2. Study startDec 2007
  3. Primary completionJun 2009
  4. Study completionJun 2009

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
86 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00565318
Sponsor's protocol ID
BENFO-1
Other IDs
NL17390.075.07
Acronym
Benfo
Status last verified
Nov 2009
First submitted
28 Nov 2007
Last updated
16 Nov 2009
Results posted
No
Data monitoring committee
No

Publications

  • Hammes HP, Du X, Edelstein D, Taguchi T, Matsumura T, Ju Q, Lin J, Bierhaus A, Nawroth P, Hannak D, Neumaier M, Bergfeld R, Giardino I, Brownlee M. Benfotiamine blocks three major pathways of hyperglycemic damage and prevents experimental diabetic retinopathy. Nat Med. 2003 Mar;9(3):294-9. doi: 10.1038/nm834. Epub 2003 Feb 18.

    PubMed 12592403

  • Bakker SJ, Heine RJ, Gans RO. Thiamine may indirectly act as an antioxidant. Diabetologia. 1997 Jun;40(6):741-2. No abstract available.

    PubMed 9222658

  • Thornalley PJ, Babaei-Jadidi R, Al Ali H, Rabbani N, Antonysunil A, Larkin J, Ahmed A, Rayman G, Bodmer CW. High prevalence of low plasma thiamine concentration in diabetes linked to a marker of vascular disease. Diabetologia. 2007 Oct;50(10):2164-70. doi: 10.1007/s00125-007-0771-4. Epub 2007 Aug 4.

    PubMed 17676306

  • Alkhalaf A, Kleefstra N, Groenier KH, Bilo HJ, Gans RO, Heeringa P, Scheijen JL, Schalkwijk CG, Navis GJ, Bakker SJ. Effect of benfotiamine on advanced glycation endproducts and markers of endothelial dysfunction and inflammation in diabetic nephropathy. PLoS One. 2012;7(7):e40427. doi: 10.1371/journal.pone.0040427. Epub 2012 Jul 6.

    PubMed 22792314

  • Alkhalaf A, Klooster A, van Oeveren W, Achenbach U, Kleefstra N, Slingerland RJ, Mijnhout GS, Bilo HJ, Gans RO, Navis GJ, Bakker SJ. A double-blind, randomized, placebo-controlled clinical trial on benfotiamine treatment in patients with diabetic nephropathy. Diabetes Care. 2010 Jul;33(7):1598-601. doi: 10.2337/dc09-2241. Epub 2010 Apr 22.

    PubMed 20413516

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Benfotiamine in people with Diabetic Nephropathy, run by University Medical Center Groningen at 1 site in Netherlands.

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 7 inclusion and 15 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: finished, as of the sponsor's last update on 16 Nov 2009. 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 Netherlands. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in urinary excretion of: - Kidney injury molecule-1 (KIM-1) - Albumin (time frame: 12 weeks). 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 NCT00565318, which also lists 5 linked publications.

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 16 Nov 2009.

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