Type 2 DiabetesPhase 4NCT01382303
Effect of Pentoxifylline on Proteinuria in Korean Type 2 Diabetic Patients
A Phase 4 study testing Pentoxifylline in people with Type 2 Diabetes, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
This multi-center, randomized controlled study aims to evaluate the effects of pentoxifylline on proteinuria in Korean type 2 diabetic patients. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Pentoxifylline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Oct 2010to 20 Dec 2013
- Phase
- Phase 4
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes mellitus
- age >=20 years
- spot urine albumin/creatinine ratio > 30mg/g in two consecutive measurements
- patients on ACE-inhibitor or ARB as an anti-hypertensive drug
- blood pressure <= 150/100 mmHg
- HbA1c <10%
Who cannot join
- taking insulin pentoxifylline, cilostazol, ketas, viagra in 3 months
- ischemic heart disease, stroke, malignant disease, severe infection in 6 months
- serum creatinine > 2.0mg/dl
- severe liver disease or AST, ALT > 3* ULM
- taking systemic steroid in 1 month
- pregnant or plan to become pregnant during the clinical trial
- lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pentoxifylline on Proteinuria in Korean Type 2 Diabetic Patients : Prospective, Randomized, Double Blinded Active Control, Multicenter Study
This multi-center, randomized controlled study aims to evaluate the effects of pentoxifylline on proteinuria in Korean type 2 diabetic patients.
Read the detailed description
The investigators will recruit adults patients with type 2 diabetes aged over 20 years with spot urine albumin to creatinine ratio over 30mg/g in two consecutive measurements.
Enrolled patients will be randomly assigned to receive pentoxifylline (400mg three times daily) or placebo for 24 weeks.
Fasting blood and spot urine will be collected at baseline, 12 weeks and 24 weeks.
The investigators will evaluate the impact of pentoxifylline on proteinuria in type 2 diabetic patients.
- Conditions
- Type 2 Diabetes
- Being tested
- Pentoxifylline, Placebo
- Keywords
- Type 2 Diabetes, pentoxifylline, proteinuria
- Medical subject headings
- Diabetes Mellitus, Type 2, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PentoxifyllineDrug
Also called Trental
Pentoxifylline 400mg three times a day
PlaceboDrug
placebo tablet three times a day
| Study group | Role | What they receive |
|---|---|---|
| Pentoxifylline | Active comparator | Pentoxifylline 400mg three times a day Receives: Drug: Pentoxifylline |
| Placebo | Placebo comparator | placebo tablet Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Proteinuia
Changes of urine protein to creatinie ratio from baseline to 24 weeks
Measured: baseline and 24 weeks
Secondary outcomes (5)
Percentage Change in Albuminuria
Changes of urine albumin to creatinie ratio from baseline to 24 weeks
Measured: baseline and 24 weeks
Mean Change of eGFR
changes in eGFR from baseline to 24 weeks
Measured: baseline and 24 weeks
Mean Change of Creatinine
changes serum creatinine from baseline to 24 weeks
Measured: baseline and 24 weeks
Mean Change of Fasting Glucose
changes serum fasting glucose from baseline to 24 weeks
Measured: baseline and 24 weeks
Mean Change of TNF-a
changes in TNF-a from baseline to 24 weeks
Measured: baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study start25 Oct 2010
- Primary completion20 Dec 2013
- Study completion20 Dec 2013
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 (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Bundang CHA Hospital, Hallym University Medical Center, Gangnam Severance Hospital, Yonsei University, Myongji Hospital
- Responsible party
- Principal investigator, Kwan Woo Lee, Ajou University School of Medicine
- Investigators
- Kwan-Woo Lee, PhD, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382303
- Sponsor's protocol ID
- AJIRB-MED-CT4-10-055
- Status last verified
- Mar 2017
- First submitted
- 22 Jun 2011
- Last updated
- 16 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.
PubMed 37916745Han SJ, Kim HJ, Kim DJ, Sheen SS, Chung CH, Ahn CW, Kim SH, Cho YW, Park SW, Kim SK, Kim CS, Kim KW, Lee KW. Effects of pentoxifylline on proteinuria and glucose control in patients with type 2 diabetes: a prospective randomized double-blind multicenter study. Diabetol Metab Syndr. 2015 Jul 19;7:64. doi: 10.1186/s13098-015-0060-1. eCollection 2015.
PubMed 26300986
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pentoxifylline on Proteinuria in Korean Type 2 Diabetic Patients : Prospective, Randomized, Double Blinded Active Control, Multicenter Study
- ClinicalTrials.gov ID
- NCT01382303
- Acronym / sponsor ID
- AJIRB-MED-CT4-10-055
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes, pentoxifylline, proteinuria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Collaborators
- Bundang CHA Hospital, Hallym University Medical Center, Gangnam Severance Hospital, Yonsei University, Myongji Hospital
- Study start
- 25 Oct 2010 (actual)
- Primary completion
- 20 Dec 2013 (actual)
- Study completion
- 20 Dec 2013 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Posted 16 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multi-center, randomized controlled study aims to evaluate the effects of pentoxifylline on proteinuria in Korean type 2 diabetic patients.
Detailed description
The investigators will recruit adults patients with type 2 diabetes aged over 20 years with spot urine albumin to creatinine ratio over 30mg/g in two consecutive measurements.
Enrolled patients will be randomly assigned to receive pentoxifylline (400mg three times daily) or placebo for 24 weeks.
Fasting blood and spot urine will be collected at baseline, 12 weeks and 24 weeks.
The investigators will evaluate the impact of pentoxifylline on proteinuria in type 2 diabetic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pentoxifylline | Active comparator | Drug: PentoxifyllinePentoxifylline 400mg three times a day |
| Placebo | Placebo comparator | Drug: Placeboplacebo tablet |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- type 2 diabetes mellitus
- age >=20 years
- spot urine albumin/creatinine ratio > 30mg/g in two consecutive measurements
- patients on ACE-inhibitor or ARB as an anti-hypertensive drug
- blood pressure <= 150/100 mmHg
Key exclusion criteria (7 listed)
- taking insulin pentoxifylline, cilostazol, ketas, viagra in 3 months
- ischemic heart disease, stroke, malignant disease, severe infection in 6 months
- serum creatinine > 2.0mg/dl
- severe liver disease or AST, ALT > 3* ULM
- taking systemic steroid in 1 month
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 |
|---|---|---|
| PentoxifyllineAlso: TrentalPentoxifylline 400mg three times a day | Drug | Pentoxifylline |
| Placeboplacebo tablet three times a day | Drug | Placebo |
Primary outcome
Percentage Change in Proteinuia
Time frame: baseline and 24 weeks
Changes of urine protein to creatinie ratio from baseline to 24 weeks
5 secondary outcomes
Percentage Change in Albuminuria
Time frame: baseline and 24 weeks
Mean Change of eGFR
Time frame: baseline and 24 weeks
Mean Change of Creatinine
Time frame: baseline and 24 weeks
Mean Change of Fasting Glucose
Time frame: baseline and 24 weeks
Mean Change of TNF-a
Time frame: baseline and 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37916745Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.
- Derived from this study: PubMed 26300986Han SJ, Kim HJ, Kim DJ, Sheen SS, Chung CH, Ahn CW, Kim SH, Cho YW, Park SW, Kim SK, Kim CS, Kim KW, Lee KW. Effects of pentoxifylline on proteinuria and glucose control in patients with type 2 diabetes: a prospective randomized double-blind multicenter study. Diabetol Metab Syndr. 2015 Jul 19;7:64. doi: 10.1186/s13098-015-0060-1. eCollection 2015.
- Individual participant dataSharing planned: No
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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.
Kwan-Woo Lee, PhD principal investigator
Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pentoxifylline in people with Type 2 Diabetes, run by Ajou University School of Medicine at 1 site in South Korea.
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 6 inclusion and 7 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 Jun 2017. 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 South Korea. 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?
Yes. Results are posted in the registry (first posted 16 Jun 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?
Percentage Change in Proteinuia (time frame: baseline and 24 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 NCT01382303, which also lists 2 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 Jun 2017.