Diabetic NephropathyPhase 2CGDNNCT01265563

N-Acetylcysteine and Milk Thistle for Treatment of Diabetic Nephropathy

A Phase 2 study testing N-acetylcysteine active and silibin active and N-acetylcysteine active + high-dose silibin active in people with Diabetic Nephropathy and Proteinuria, run by VA Office of Research and Development at 1 site in United States.

Completed

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

Official record

Search all trials

Trial summary

The study is done to find out whether the combined use of the nutritional supplements N-acetylcysteine and Siliphos (milk thistle extract) corrects the shedding of urine protein and oxidative damage (damage to cells and organs often compared to fast aging) in patients with Type 2 Diabetes Mellitus (T2DM) and diabetic… Read more about this study

Who is it for?: Ages 18 to 76 years
Conditions the study is for: Diabetic Nephropathy, Proteinuria, Oxidative Stress
What is being tested?: N-acetylcysteine active and silibin active and N-acetylcysteine active + high-dose silibin active
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 108 participants
Where: 1 siteUnited States
Study dates: Jan 2011to Dec 2016
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 to 76 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males or females age 18-76 years old
Type 2 diabetes mellitus
Diabetic nephropathy, as defined by:
estimated GFR between 60 and 15 ml/min
presence of proteinuria
Current medical treatment with low dose aspirin

Show all 12Show fewer

Treatment of hypertension with (but not limited to):
one diuretic
one beta-blocker
and one medication from the classes Angiotensin Receptor Blockers (ARBs) or Angiotensin Converting Enzyme inhibitors (ACE-I)
Treatment of hyperglycemia with (but not limited to) glipizide and the medication class insulin
Treatment of hypercholesterolemia with (but not limited to) one medication from the class statins

Who cannot join

Type 1 diabetes mellitus
Glycosylated hemoglobin (HbA1C) > 10%
>20% variation in estimated GFR, during last 6 months
Systolic Blood Pressure >170 mmHg or Diastolic Blood Pressure >100 mmHg on medications
Other secondary forms of hypertension (endocrine, renovascular)
History of intolerance to:

Show all 40Show fewer

Both ACE-I and ARBs
The investigational supplements
Iodinated radiologic contrast material
Known non diabetic renal disease
or history of solid organ transplantation
Hepatitis virus or Human Immunodeficiency virus infections
Use of one of the following medications within 2 months prior to enrollment in the study:
Metformin
Thiazolidinediones (pioglitazone or rosiglitazone)
Phenytoin
Warfarin
Prescription-grade vitamin E, vitamin C, systemic steroids, and/or non-steroidal anti-inflammatory agents
Over-the-counter vitamin E, vitamin C, and/or non-steroidal anti-inflammatory agents
Over-the-counter antioxidants supplements including:
Lipoic acid
Coenzyme Q10
N-acetyl-cysteine (NAC)
Glutathione (GSH)
Chromium
Fish-oil extracts (omega-3 fatty acids)
Soy extracts (isoflavones)
Milk thistle extract (silymarin)
Green-tea preparations
Pomegranate extracts
Grape extracts
Prickly pear extract
Active coronary artery disease or cerebral vascular disease within 3 months prior to signing the informed consent
Hepatic dysfunction as defined by abnormal total bilirubin or liver enzymes (ALT, AST) >2 times upper limit of normal range
Active malignancy
History of drug or alcohol dependency
Psychiatric or neurological condition, preventing aware consent to the study and/or adherence to the study protocol
Unwillingness to practice birth control throughout the study
Participation to another clinical study within 1 month prior to signing the informed consent form
Planned move to outside the study area, surgery or radiographic studies utilizing iodine-based contrast material within the next one year

Trial locations and contacts

1 site in 1 country.

United States1 site

South Texas Health Care System, San Antonio, TX
San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: Correction of Glutathione Deficiency for Treatment of Diabetic Nephropathy

Read the detailed description

Oxidative stress and glutathione (GSH) imbalance are major contributors to the pathogenesis of diabetic nephropathy. Current options for the treatment of oxidative stress in diabetic nephropathy are limited and only partially effective, thus interest in the development of new strategies is high.

The study intends to test the hypothesis that combined oral supplementation of the antioxidants N-acetylcysteine (NAC) and milk thistle flavonolignan silibin (as silibin-phosphatidylcholine) will reduce proteinuria and urinary and systemic manifestations of oxidative stress and inflammation, which are characteristically observed in patients with T2DM and related nephropathy. The investigators expect these effects to be achieved with minimal or no side effects, and with good patient tolerance.

The trial is designed as a two-center, double-blind, placebo-controlled, randomized, modified-factorial dose-ranging design, five-arm pilot study in patients with Type 2 diabetes mellitus and advanced diabetic nephropathy with proteinuria.

Intervention consists of three-month oral administration of NAC, silibin, and/or respective placebos for three months. Subjects are randomized to the following five intervention arms: (A) placebo; (B) NAC; (C) silibin; (D) NAC + silibin; and (E) NAC + double-dose silibin.

The primary outcome measure is urinary excretion of albumin, a marker of glomerular injury. Secondary outcome measures are alpha-1 microglobulin, a marker of tubular injury, and urinary excretion of inflammatory cytokines and C-C chemokines, i.e. markers of renal inflammation. In addition, peripheral blood monocytes from the same patients are analyzed for GSH content and activity of GSH metabolizing enzymes. All outcome measures are monitored in relation to both treatment allocation and prevalent blood and urine levels of the active treatment. Safety and tolerability of this combination treatment are monitored throughout the trial.

Conditions: Diabetic Nephropathy, Proteinuria, Oxidative Stress
Being tested: N-acetylcysteine placebo and silibin placebo, N-acetylcysteine active and silibin placebo, N-acetylcysteine placebo and silibin active, N-acetylcysteine active and silibin active, N-acetylcysteine active + high-dose silibin active
Keywords: silymarin, glutathione, diabetic nephropathies, oxidative stress, N-acetylcysteine, protein tholation
Medical subject headings: Diabetic Nephropathies, Proteinuria

What participants receive

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

N-acetylcysteine placebo and silibin placeboDrug
Also called NAC placebo, Silibin-phosphatidylcholine placebo, Siliphos placebo
Dietary Supplement: N-acetylcysteine placebo excipient and silibin placebo orally twice daily for three months
N-acetylcysteine active and silibin placeboDrug
Also called NAC, Silibin-phosphatidylcholine placebo, Siliphos placebo
Dietary Supplement: N-acetylcysteine 600 mg orally twice daily and silibin placebo orally twice a day for three months
N-acetylcysteine placebo and silibin activeDrug
Also called NAC Placebo, Silibin-phosphatidylcholine, Siliphos
Dietary Supplement: silibin 480 mg orally twice daily and N-acetylcysteine placebo orally twice a day for three months
N-acetylcysteine active and silibin activeDrug
Also called NAC, Silibin-phosphatidylcholine, Siliphos
Dietary Supplement: N-acetylcysteine 600 mg orally twice daily and silibin 480 mg orally twice daily for three months
N-acetylcysteine active + high-dose silibin activeDrug
Also called NAC, Silibin-phosphatidylcholine, Siliphos
Dietary Supplement: N-acetylcysteine 600 mg orally twice daily and silibin 960 mg orally twice daily for three months

Study groups in NCT01265563
Study group	Role	What they receive
NAC placebo and Silibin placebo	Placebo comparator	Drug: N-acetylcysteine placebo and Drug: Silibin placebo Receives: Drug: N-acetylcysteine placebo and silibin placebo
NAC active and Silibin placebo	Experimental	Drug: N-acetylcysteine and Drug: Silibin placebo Receives: Drug: N-acetylcysteine active and silibin placebo
NAC placebo and Silibin active	Experimental	Drug: N-acetylcysteine placebo and Drug: Silibin active Receives: Drug: N-acetylcysteine placebo and silibin active
NAC active and Silibin active	Experimental	Drug: N-acetylcysteine active and Drug: Silibin active Receives: Drug: N-acetylcysteine active and silibin active
NAC active and High-dose Silibin active	Experimental	Drug: N-acetylcysteine active and Drug: Silibin higher dose active Receives: Drug: N-acetylcysteine active + high-dose silibin active

What is being measured

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

Change From Baseline in Urinary Albumin Excretion
Urine albumin to creatinine ratio was assessed at the end of run in period and after 3 months administration of study intervention.
Measured: Baseline and 3 months

Secondary outcomes (2)

Change From Baseline in Hemoglobin-A1c
Hemoglobin A1C was assessed at the end of the run in period and after 3 months of administration of study interventions. Here is delta HgA1C is reported between the two periods
Measured: Baseline and 3 months
Urinary Alpha-1 Microglobulin, Inflammatory Cytokines and C-C Chemokines
Urinary alpha-1 microglobulin, inflammatory cytokines and C-C chemokines were never measured and analyzed.
Measured: Baseline and 3 months

Timeline

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

Jan 2011Dec 2016

First posted23 Dec 2010 (estimated)
Study startJan 2011
Primary completionFeb 2015
Study completionDec 2016

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.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Diabetic NephropathyStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01265563
Sponsor's protocol ID: CLIN-004-10S
Other IDs: 1R21AT004490-01A1, VA 1I01CX000264-01A2
Acronym: CGDN
Status last verified: Sep 2018
First submitted: 10 Dec 2010
Last updated: 19 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Undecided

Publications

Debnath S, Thameem F, Alves T, Nolen J, Al-Shahrouri H, Bansal S, Abboud HE, Fanti P. Diabetic nephropathy among Mexican Americans. Clin Nephrol. 2012 Apr;77(4):332-44. doi: 10.5414/cn107487.
PubMed 22445478
Giustarini D, Dalle-Donne I, Milzani A, Fanti P, Rossi R. Analysis of GSH and GSSG after derivatization with N-ethylmaleimide. Nat Protoc. 2013 Sep;8(9):1660-9. doi: 10.1038/nprot.2013.095. Epub 2013 Aug 1.
PubMed 23928499
Khazim K, Giustarini D, Rossi R, Verkaik D, Cornell JE, Cunningham SE, Mohammad M, Trochta K, Lorenzo C, Folli F, Bansal S, Fanti P. Glutathione redox potential is low and glutathionylated and cysteinylated hemoglobin levels are elevated in maintenance hemodialysis patients. Transl Res. 2013 Jul;162(1):16-25. doi: 10.1016/j.trsl.2012.12.014. Epub 2013 Jan 17.
PubMed 23333585
Cunningham SE, Verkaik D, Gross G, Khazim K, Hirachan P, Agarwal G, Lorenzo C, Matteucci E, Bansal S, Fanti P. Comparison of Nutrition Profile and Diet Record Between Veteran and Nonveteran End-Stage Renal Disease Patients Receiving Hemodialysis in Veterans Affairs and Community Clinics in Metropolitan South-Central Texas. Nutr Clin Pract. 2015 Oct;30(5):698-708. doi: 10.1177/0884533615575046. Epub 2015 Apr 21.
PubMed 25899538
Fanti P, Giustarini D, Rossi R, Cunningham SE, Folli F, Khazim K, Cornell J, Matteucci E, Bansal S. Dietary Intake of Proteins and Calories Is Inversely Associated With The Oxidation State of Plasma Thiols in End-Stage Renal Disease Patients. J Ren Nutr. 2015 Nov;25(6):494-503. doi: 10.1053/j.jrn.2015.06.003. Epub 2015 Jul 31.
PubMed 26235932
Giustarini D, Galvagni F, Orlandini M, Fanti P, Rossi R. Immediate stabilization of human blood for delayed quantification of endogenous thiols and disulfides. J Chromatogr B Analyt Technol Biomed Life Sci. 2016 Apr 15;1019:51-8. doi: 10.1016/j.jchromb.2016.02.009. Epub 2016 Feb 8.
PubMed 26896310
Khazim K, Gorin Y, Cavaglieri RC, Abboud HE, Fanti P. The antioxidant silybin prevents high glucose-induced oxidative stress and podocyte injury in vitro and in vivo. Am J Physiol Renal Physiol. 2013 Sep 1;305(5):F691-700. doi: 10.1152/ajprenal.00028.2013. Epub 2013 Jun 26.
PubMed 23804455

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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All Diabetic Nephropathy trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Correction of Glutathione Deficiency for Treatment of Diabetic Nephropathy
ClinicalTrials.gov ID: NCT01265563
Acronym / sponsor ID: CGDN / CLIN-004-10S
Conditions: Diabetic Nephropathy, Proteinuria, Oxidative Stress
Keywords: silymarin, glutathione, diabetic nephropathies, oxidative stress, N-acetylcysteine, protein tholation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 108 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Study start: Jan 2011
Primary completion: Feb 2015 (actual)
Study completion: Dec 2016 (actual)
First posted: 23 Dec 2010 (estimated)
Results: Posted 31 Mar 2017

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: Triple blind (participant, care provider, investigator)
Number of arms: 5

Arm	Type	Receives
NAC placebo and Silibin placebo	Placebo comparator	Drug: N-acetylcysteine placebo and silibin placeboDrug: N-acetylcysteine placebo and Drug: Silibin placebo
NAC active and Silibin placebo	Experimental	Drug: N-acetylcysteine active and silibin placeboDrug: N-acetylcysteine and Drug: Silibin placebo
NAC placebo and Silibin active	Experimental	Drug: N-acetylcysteine placebo and silibin activeDrug: N-acetylcysteine placebo and Drug: Silibin active
NAC active and Silibin active	Experimental	Drug: N-acetylcysteine active and silibin activeDrug: N-acetylcysteine active and Drug: Silibin active
NAC active and High-dose Silibin active	Experimental	Drug: N-acetylcysteine active + high-dose silibin activeDrug: N-acetylcysteine active and Drug: Silibin higher dose active

Who may qualify

Ages: 18 to 76 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Males or females age 18-76 years old
Type 2 diabetes mellitus
Diabetic nephropathy, as defined by:
Current medical treatment with low dose aspirin
Treatment of hypertension with (but not limited to):

Key exclusion criteria (40 listed)

Type 1 diabetes mellitus
Glycosylated hemoglobin (HbA1C) > 10%
>20% variation in estimated GFR, during last 6 months
Systolic Blood Pressure >170 mmHg or Diastolic Blood Pressure >100 mmHg on medications
Other secondary forms of hypertension (endocrine, renovascular)

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
N-acetylcysteine placebo and silibin placeboAlso: NAC placebo, Silibin-phosphatidylcholine placebo, Siliphos placeboDietary Supplement: N-acetylcysteine placebo excipient and silibin placebo orally twice daily for three months	Drug	NAC placebo and Silibin placebo
N-acetylcysteine active and silibin placeboAlso: NAC, Silibin-phosphatidylcholine placebo, Siliphos placeboDietary Supplement: N-acetylcysteine 600 mg orally twice daily and silibin placebo orally twice a day for three months	Drug	NAC active and Silibin placebo
N-acetylcysteine placebo and silibin activeAlso: NAC Placebo, Silibin-phosphatidylcholine, SiliphosDietary Supplement: silibin 480 mg orally twice daily and N-acetylcysteine placebo orally twice a day for three months	Drug	NAC placebo and Silibin active
N-acetylcysteine active and silibin activeAlso: NAC, Silibin-phosphatidylcholine, SiliphosDietary Supplement: N-acetylcysteine 600 mg orally twice daily and silibin 480 mg orally twice daily for three months	Drug	NAC active and Silibin active
N-acetylcysteine active + high-dose silibin activeAlso: NAC, Silibin-phosphatidylcholine, SiliphosDietary Supplement: N-acetylcysteine 600 mg orally twice daily and silibin 960 mg orally twice daily for three months	Drug	NAC active and High-dose Silibin active

Primary outcome

Change From Baseline in Urinary Albumin Excretion
Time frame: Baseline and 3 months
Urine albumin to creatinine ratio was assessed at the end of run in period and after 3 months administration of study intervention.

2 secondary outcomes

Change From Baseline in Hemoglobin-A1c
Time frame: Baseline and 3 months
Urinary Alpha-1 Microglobulin, Inflammatory Cytokines and C-C Chemokines
Time frame: Baseline and 3 months

Results and safety

Results posted to the registry on 31 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NAC Placebo + Silibin Placebo	16	16
NAC Active + Silibin Placebo	13	12
NAC Placebo + Silibin Active	17	16
NAC Active + Silibin Active	16	16
NAC Active + High Dose Silibin Active	16	14

Primary outcome: Change From Baseline in Urinary Albumin Excretion

Time frame: Baseline and 3 months. Mean (Standard Deviation). Unit: mg/g

Measure	NAC Placebo + Silibin Placebo n = 16	NAC Active + Silibin Placebo n = 12	NAC Placebo + Silibin Active n = 16	NAC Active + Silibin Active n = 16	NAC Active + High-dose Silibin Active n = 14
Value	50.5 (291.2)	-28.13 (578.32)	-4.5 (541)	96.6 (422.4)	353.71 (732.67)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NAC Placebo + Silibin Placebo	1 of 16 (6.3%)	7 of 16 (43.8%)	0 of 16
NAC Active + Silibin Placebo	1 of 12 (8.3%)	7 of 12 (58.3%)	0 of 12
NAC Placebo + Silibin Active	1 of 16 (6.3%)	6 of 16 (37.5%)	0 of 16
NAC Active + Silibin Active	1 of 16 (6.3%)	8 of 16 (50%)	0 of 16
NAC Active + High-dose Silibin Active	1 of 14 (7.1%)	9 of 14 (64.3%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22445478Debnath S, Thameem F, Alves T, Nolen J, Al-Shahrouri H, Bansal S, Abboud HE, Fanti P. Diabetic nephropathy among Mexican Americans. Clin Nephrol. 2012 Apr;77(4):332-44. doi: 10.5414/cn107487.
Background: PubMed 23928499Giustarini D, Dalle-Donne I, Milzani A, Fanti P, Rossi R. Analysis of GSH and GSSG after derivatization with N-ethylmaleimide. Nat Protoc. 2013 Sep;8(9):1660-9. doi: 10.1038/nprot.2013.095. Epub 2013 Aug 1.
Results publication: PubMed 23333585Khazim K, Giustarini D, Rossi R, Verkaik D, Cornell JE, Cunningham SE, Mohammad M, Trochta K, Lorenzo C, Folli F, Bansal S, Fanti P. Glutathione redox potential is low and glutathionylated and cysteinylated hemoglobin levels are elevated in maintenance hemodialysis patients. Transl Res. 2013 Jul;162(1):16-25. doi: 10.1016/j.trsl.2012.12.014. Epub 2013 Jan 17.
Results publication: PubMed 25899538Cunningham SE, Verkaik D, Gross G, Khazim K, Hirachan P, Agarwal G, Lorenzo C, Matteucci E, Bansal S, Fanti P. Comparison of Nutrition Profile and Diet Record Between Veteran and Nonveteran End-Stage Renal Disease Patients Receiving Hemodialysis in Veterans Affairs and Community Clinics in Metropolitan South-Central Texas. Nutr Clin Pract. 2015 Oct;30(5):698-708. doi: 10.1177/0884533615575046. Epub 2015 Apr 21.
Results publication: PubMed 26235932Fanti P, Giustarini D, Rossi R, Cunningham SE, Folli F, Khazim K, Cornell J, Matteucci E, Bansal S. Dietary Intake of Proteins and Calories Is Inversely Associated With The Oxidation State of Plasma Thiols in End-Stage Renal Disease Patients. J Ren Nutr. 2015 Nov;25(6):494-503. doi: 10.1053/j.jrn.2015.06.003. Epub 2015 Jul 31.
Results publication: PubMed 26896310Giustarini D, Galvagni F, Orlandini M, Fanti P, Rossi R. Immediate stabilization of human blood for delayed quantification of endogenous thiols and disulfides. J Chromatogr B Analyt Technol Biomed Life Sci. 2016 Apr 15;1019:51-8. doi: 10.1016/j.jchromb.2016.02.009. Epub 2016 Feb 8.
Results publication: PubMed 23804455Khazim K, Gorin Y, Cavaglieri RC, Abboud HE, Fanti P. The antioxidant silybin prevents high glucose-induced oxidative stress and podocyte injury in vitro and in vivo. Am J Physiol Renal Physiol. 2013 Sep 1;305(5):F691-700. doi: 10.1152/ajprenal.00028.2013. Epub 2013 Jun 26.
Individual participant dataSharing planned: Undecided

Related trials for Diabetic Nephropathy

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Beta-2-Trace Protein in Diabetic Nephropathy
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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.

Paolo Fanti, MD principal investigator

South Texas Health Care System, San Antonio, TX

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

Questions about this trial

What is this clinical trial studying?

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 12 inclusion and 40 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 19 Oct 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 31 Mar 2017). 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?

Change From Baseline in Urinary Albumin Excretion (time frame: Baseline and 3 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 NCT01265563, which also lists 7 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 19 Oct 2018; AzTrials last refreshed its copy on 8 Nov 2026.