Diabetes MellitusPhase 1/2NCT00063583
Pirfenidone: A New Drug to Treat Kidney Disease in Patients With Diabetes
A Phase 1/2 study testing Pirfenidone in people with Diabetes Mellitus and Diabetic Nephropathy, run by Sharma, Kumar, M.D. at 3 sites in United States.
Trial summary
The purpose of this study is to determine whether a new investigational drug, pirfenidone, will be an effective therapy for diabetic patients with kidney dysfunction. Our hypothesis is that administration of pirfenidone to type 1 and type 2 diabetic patients with advanced kidney disease will lead to preservation of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Diabetic Nephropathy
- What is being tested?
- Pirfenidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2003to Mar 2009
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 or type 2 diabetes
- Males and females greater than or equal to 18 years.
- Abnormal kidney function determined by glomerular filtration rate
- History of proteinuria
- Blood pressure controlled to <140/90 on anti-hypertensive medication
Who cannot join
- Cancer, liver disease, hepatitis, HIV+
- History of heart attack, unstable angina, stroke or peptic ulcer in the past 6 months
- Pregnant or planning to become pregnant during the study period
- Other known kidney disease besides diabetic nephropathy
- Expect to begin dialysis or receive a kidney transplant within 1 year of study enrollment
Trial locations and contacts
3 sites in 1 country.
United States3 sites
National Institute of Diabetes and Digestive and Kidney Disease (NIDDK)
Bethesda, Maryland, 20892
The Center for Diabetic Kidney Disease at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Pirfenidone: A Novel Anti-Scarring Therapy for Diabetic Nephropathy
The purpose of this study is to determine whether a new investigational drug, pirfenidone, will be an effective therapy for diabetic patients with kidney dysfunction. Our hypothesis is that administration of pirfenidone to type 1 and type 2 diabetic patients with advanced kidney disease will lead to preservation of kidney function.
Read the detailed description
Diabetic kidney disease is the leading cause of new cases of kidney failure in the United States. In the kidneys of diabetic patients, there is accumulation of protein that leads to the formation of scar tissue and poor kidney function. Because of this many patients eventually require dialysis or kidney transplantation. A new investigational drug, pirfenidone, has been shown to be beneficial in a number of diseases in which scar formation leads to disease progression. It is our goal to examine whether pirfenidone is effective at stabilizing or reducing progressive diabetic kidney dysfunction.
- Conditions
- Diabetes Mellitus, Diabetic Nephropathy
- Being tested
- Pirfenidone
- Keywords
- Kidney disease
- Medical subject headings
- Diabetes Mellitus, Diabetic Nephropathies, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PirfenidoneDrug
Pirfenidone will be administered orally at 1200 or 2400 mg day in divided doses
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Pirfenidone |
| Pirfenidone 1200 mg/day | Experimental | Pirfenidone will be administered at a dose of 1200 mg/day Receives: Drug: Pirfenidone |
| Pirfenidone 2400 mg/day | Experimental | Pirfenidone will be administered at 2400 mg/day Receives: Drug: Pirfenidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be the change in renal function from baseline to the end of the study period (12 months).
Measured: 12 months
Secondary outcomes (3)
% change in urine albumin excretion from baseline to end of study period.
Measured: 12 months
% change in levels of TGF-b1 in urine, plasma and serum from baseline to end of study period.
Measured: 12 months
• Determine the relationship between % change in TGF-b1 levels and the change in GFR
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2003 (estimated)
- Study startJun 2003
- Primary completionNov 2007
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sharma, Kumar, M.D.
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Investigators
- Kumar Sharma, M.D., Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00063583
- Sponsor's protocol ID
- 1R01DK063017-01
- Other IDs
- R01DK063017
- Status last verified
- Nov 2009
- First submitted
- 30 Jun 2003
- Last updated
- 4 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sharma K, Ziyadeh FN, Alzahabi B, McGowan TA, Kapoor S, Kurnik BR, Kurnik PB, Weisberg LS. Increased renal production of transforming growth factor-beta1 in patients with type II diabetes. Diabetes. 1997 May;46(5):854-9. doi: 10.2337/diab.46.5.854.
PubMed 9133555Shimizu F, Fukagawa M, Yamauchi S, Taniyama M, Komemushi S, Margolin SB, Kurokawa K: Pirfenidone prevents the progression of irreversible glomerular sclerotic lesions in rats. Nephrology 3:315-322, 1997
Shimizu T, Fukagawa M, Kuroda T, Hata S, Iwasaki Y, Nemoto M, Shirai K, Yamauchi S, Margolin SB, Shimizu F, Kurokawa K. Pirfenidone prevents collagen accumulation in the remnant kidney in rats with partial nephrectomy. Kidney Int Suppl. 1997 Dec;63:S239-43.
PubMed 9407470Iyer SN, Gurujeyalakshmi G, Giri SN. Effects of pirfenidone on transforming growth factor-beta gene expression at the transcriptional level in bleomycin hamster model of lung fibrosis. J Pharmacol Exp Ther. 1999 Oct;291(1):367-73.
PubMed 10490926McGowan T, Dunn SR, Sharma K: Treatment of db/db mice with pirfenidone leads to improved histology and serum creatinine. J Am Soc Nephrology 11:A2814, 2000
Raghu G, Johnson WC, Lockhart D, Mageto Y. Treatment of idiopathic pulmonary fibrosis with a new antifibrotic agent, pirfenidone: results of a prospective, open-label Phase II study. Am J Respir Crit Care Med. 1999 Apr;159(4 Pt 1):1061-9. doi: 10.1164/ajrccm.159.4.9805017.
PubMed 10194146
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pirfenidone: A Novel Anti-Scarring Therapy for Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT00063583
- Acronym / sponsor ID
- 1R01DK063017-01
- Conditions
- Diabetes Mellitus, Diabetic Nephropathy
- Keywords
- Kidney disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Sharma, Kumar, M.D.
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jun 2003
- Primary completion
- Nov 2007 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 2 Jul 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a new investigational drug, pirfenidone, will be an effective therapy for diabetic patients with kidney dysfunction. Our hypothesis is that administration of pirfenidone to type 1 and type 2 diabetic patients with advanced kidney disease will lead to preservation of kidney function.
Detailed description
Diabetic kidney disease is the leading cause of new cases of kidney failure in the United States. In the kidneys of diabetic patients, there is accumulation of protein that leads to the formation of scar tissue and poor kidney function. Because of this many patients eventually require dialysis or kidney transplantation. A new investigational drug, pirfenidone, has been shown to be beneficial in a number of diseases in which scar formation leads to disease progression. It is our goal to examine whether pirfenidone is effective at stabilizing or reducing progressive diabetic kidney dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PirfenidonePlacebo |
| Pirfenidone 1200 mg/day | Experimental | Drug: PirfenidonePirfenidone will be administered at a dose of 1200 mg/day |
| Pirfenidone 2400 mg/day | Experimental | Drug: PirfenidonePirfenidone will be administered at 2400 mg/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 1 or type 2 diabetes
- Males and females greater than or equal to 18 years.
- Abnormal kidney function determined by glomerular filtration rate
- History of proteinuria
- Blood pressure controlled to <140/90 on anti-hypertensive medication
Key exclusion criteria (5 listed)
- Cancer, liver disease, hepatitis, HIV+
- History of heart attack, unstable angina, stroke or peptic ulcer in the past 6 months
- Pregnant or planning to become pregnant during the study period
- Other known kidney disease besides diabetic nephropathy
- Expect to begin dialysis or receive a kidney transplant within 1 year of study enrollment
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 |
|---|---|---|
| PirfenidonePirfenidone will be administered orally at 1200 or 2400 mg day in divided doses | Drug | Pirfenidone 1200 mg/day, Pirfenidone 2400 mg/day, Placebo |
Primary outcome
The primary endpoint will be the change in renal function from baseline to the end of the study period (12 months).
Time frame: 12 months
3 secondary outcomes
% change in urine albumin excretion from baseline to end of study period.
Time frame: 12 months
% change in levels of TGF-b1 in urine, plasma and serum from baseline to end of study period.
Time frame: 12 months
• Determine the relationship between % change in TGF-b1 levels and the change in GFR
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2009.
- Background: PubMed 9133555Sharma K, Ziyadeh FN, Alzahabi B, McGowan TA, Kapoor S, Kurnik BR, Kurnik PB, Weisberg LS. Increased renal production of transforming growth factor-beta1 in patients with type II diabetes. Diabetes. 1997 May;46(5):854-9. doi: 10.2337/diab.46.5.854.
- BackgroundShimizu F, Fukagawa M, Yamauchi S, Taniyama M, Komemushi S, Margolin SB, Kurokawa K: Pirfenidone prevents the progression of irreversible glomerular sclerotic lesions in rats. Nephrology 3:315-322, 1997
- Background: PubMed 9407470Shimizu T, Fukagawa M, Kuroda T, Hata S, Iwasaki Y, Nemoto M, Shirai K, Yamauchi S, Margolin SB, Shimizu F, Kurokawa K. Pirfenidone prevents collagen accumulation in the remnant kidney in rats with partial nephrectomy. Kidney Int Suppl. 1997 Dec;63:S239-43.
- Background: PubMed 10490926Iyer SN, Gurujeyalakshmi G, Giri SN. Effects of pirfenidone on transforming growth factor-beta gene expression at the transcriptional level in bleomycin hamster model of lung fibrosis. J Pharmacol Exp Ther. 1999 Oct;291(1):367-73.
- BackgroundMcGowan T, Dunn SR, Sharma K: Treatment of db/db mice with pirfenidone leads to improved histology and serum creatinine. J Am Soc Nephrology 11:A2814, 2000
- Background: PubMed 10194146Raghu G, Johnson WC, Lockhart D, Mageto Y. Treatment of idiopathic pulmonary fibrosis with a new antifibrotic agent, pirfenidone: results of a prospective, open-label Phase II study. Am J Respir Crit Care Med. 1999 Apr;159(4 Pt 1):1061-9. doi: 10.1164/ajrccm.159.4.9805017.
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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.
Kumar Sharma, M.D. principal investigator
UCSD
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pirfenidone in people with Diabetes Mellitus and Diabetic Nephropathy, run by Sharma, Kumar, M.D. at 3 sites 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 5 inclusion and 5 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 4 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 3 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
The primary endpoint will be the change in renal function from baseline to the end of the study period (12 months). (time frame: 12 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 NCT00063583, which also lists 6 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 4 Nov 2009.