Diabetes MellitusPhase 3NCT00507494
Influence of Pioglitazone for Renal Transplant Function in Diabetics
A Phase 3 study testing pioglitazone in people with Diabetes Mellitus and Kidney Transplantation, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
The purpose of this study is to test whether pioglitazone is able to prevent the progression of diabetic nephropathy in kidney transplant recipients with diabetes mellitus. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Kidney Transplantation, Proteinuria
- What is being tested?
- pioglitazone
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Jul 2007to Sep 2009
- Phase
- Phase 3
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- kidney transplantation(> 6 months ago) ; stable graft function
- diabetes mellitus type 2
- acceptable glycemia (HbA1c < 8%)
- creatinin clearance (MDRD)>30 ml/min 1,73m²)
- proteinuria > 30 mg/24 hr
Who cannot join
- type 1 diabetes
- pregnant or breast feeding women
- congestive heart failure (>stage 1 NYHA)
- creeping creatinin
- treatment for rejection within 3 months prior to inclusion
- ALT, AST > 2.5 fold the upper limit of normal
- uncontrolled hypertension
- hypo- or hyperthyroidism
Trial locations and contacts
1 site in 1 country.
Germany1 site
Nephrology, Department of Medicine, university hospital Dresden
Dresden, 01307
About this study
Official title: Influence of Pioglitazone for Renal Transplant Function in Diabetics - a Double Blind Randomised Placebo Controlled Cross Over Study
The purpose of this study is to test whether pioglitazone is able to prevent the progression of diabetic nephropathy in kidney transplant recipients with diabetes mellitus.
Read the detailed description
About 30 % of kidney transplant recipients will develop diabetes mellitus. This condition is a risk factor for graft dysfunction, graft loss and increased mortality of patients. Inflammatory reactions within the graft and proteinuria are considered as pathogenetic mechanisms.
Recent studies indicated that pioglitazone might have beneficial effects on the urinary protein excretion of type 2 diabetic patients with diabetic nephropathy and was able to reduce systemic inflammation.
This lead to the hypothesis that pioglitazone could improve proteinuria of kidney transplant patients with diabetes.
Comparison: Effects of pioglitazone vs. placebo on proteinuria and renal function of kidney transplant recipients in a cross over study.
- Conditions
- Diabetes Mellitus, Kidney Transplantation, Proteinuria
- Being tested
- pioglitazone
- Keywords
- posttransplant diabetes mellitus, kidney transplantation, filtration fraction, proteinuria
- Medical subject headings
- Diabetes Mellitus, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pioglitazoneDrug
Pioglitazone 30 mg o.d. tablet for 12 weeks or placebo o.d. tablet for 12 weeks in random order. After 12 wk treatment there is a 4 wk washout out which is followed by switch of study medication in a cross over fashion and a further 12 wk treatment.
What is being measured
The primary outcome is the main question the study is designed to answer.
proteinuria
Measured: 12 weeks
Secondary outcomes (1)
efficacy: filtration fraction, renal nitric oxide bioavailability, insulin resistance, platelet function safety: tolerability, plasma glucose, body weight, edema
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Gross, MD, Principal investigator, Nephrology, Department of Medicine, University hospital Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507494
- Sponsor's protocol ID
- DNTx
- Status last verified
- Oct 2011
- First submitted
- 25 Jul 2007
- Last updated
- 28 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lo C, Toyama T, Oshima M, Jun M, Chin KL, Hawley CM, Zoungas S. Glucose-lowering agents for treating pre-existing and new-onset diabetes in kidney transplant recipients. Cochrane Database Syst Rev. 2020 Jul 30;8(8):CD009966. doi: 10.1002/14651858.CD009966.pub3.
PubMed 32803882
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Pioglitazone for Renal Transplant Function in Diabetics - a Double Blind Randomised Placebo Controlled Cross Over Study
- ClinicalTrials.gov ID
- NCT00507494
- Acronym / sponsor ID
- DNTx
- Conditions
- Diabetes Mellitus, Kidney Transplantation, Proteinuria
- Keywords
- posttransplant diabetes mellitus, kidney transplantation, filtration fraction, proteinuria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 26 Jul 2007 (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 test whether pioglitazone is able to prevent the progression of diabetic nephropathy in kidney transplant recipients with diabetes mellitus.
Detailed description
About 30 % of kidney transplant recipients will develop diabetes mellitus. This condition is a risk factor for graft dysfunction, graft loss and increased mortality of patients. Inflammatory reactions within the graft and proteinuria are considered as pathogenetic mechanisms.
Recent studies indicated that pioglitazone might have beneficial effects on the urinary protein excretion of type 2 diabetic patients with diabetic nephropathy and was able to reduce systemic inflammation.
This lead to the hypothesis that pioglitazone could improve proteinuria of kidney transplant patients with diabetes.
Comparison: Effects of pioglitazone vs. placebo on proteinuria and renal function of kidney transplant recipients in a cross over study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- kidney transplantation(> 6 months ago) ; stable graft function
- diabetes mellitus type 2
- acceptable glycemia (HbA1c < 8%)
- creatinin clearance (MDRD)>30 ml/min 1,73m²)
- proteinuria > 30 mg/24 hr
Key exclusion criteria (8 listed)
- type 1 diabetes
- pregnant or breast feeding women
- congestive heart failure (>stage 1 NYHA)
- creeping creatinin
- treatment for rejection within 3 months prior to inclusion
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 |
|---|---|---|
| pioglitazonePioglitazone 30 mg o.d. tablet for 12 weeks or placebo o.d. tablet for 12 weeks in random order. After 12 wk treatment there is a 4 wk washout out which is followed by switch of study medication in a cross over fashion and a further 12 wk treatment. | Drug | – |
Primary outcome
proteinuria
Time frame: 12 weeks
1 secondary outcome
efficacy: filtration fraction, renal nitric oxide bioavailability, insulin resistance, platelet function safety: tolerability, plasma glucose, body weight, edema
Time frame: 12 weeks
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 28 Oct 2011.
- Derived from this study: PubMed 32803882Lo C, Toyama T, Oshima M, Jun M, Chin KL, Hawley CM, Zoungas S. Glucose-lowering agents for treating pre-existing and new-onset diabetes in kidney transplant recipients. Cochrane Database Syst Rev. 2020 Jul 30;8(8):CD009966. doi: 10.1002/14651858.CD009966.pub3.
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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.
Peter Gross, MD principal investigator
Nephrology, Department of Medicine, University hospital Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pioglitazone in people with Diabetes Mellitus and Kidney Transplantation, run by Technische Universität Dresden at 1 site in Germany.
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 8 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 28 Oct 2011. 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 Germany. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
proteinuria (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 NCT00507494, which also lists 1 linked publication.
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 28 Oct 2011.