Diabetic NephropathyPhase 2NCT00287183
6-Month Safety And Efficacy Study Of TTP488 In Patients With Type 2 Diabetes And Persistent Albuminuria
A Phase 2 study testing PF-04494700 (TTP488) in people with Diabetic Nephropathy, run by Pfizer at 19 sites in Canada.
Trial summary
Current research indicates that TTP488 may be a viable agent for the treatment of diabetic nephropathy. The purpose of this study is to determine the safety and efficacy of a six-month regimen of daily orally-administered TTP488 to patients with diabetic nephropathy. Read more about this study
- Who is it for?
- Ages 31 years and older
- Conditions the study is for
- Diabetic Nephropathy
- What is being tested?
- PF-04494700 (TTP488)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 19 sitesCanada
- Study dates
- Feb 2006to Aug 2009
- Phase
- Phase 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 31 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female outpatients 31 years of age or older.
- Females must no longer be of child-bearing potential, must have a negative serum pregnancy test, and cannot be breast-feeding.
- Non-vasectomized male must be willing to abstain from sexual intercourse or willing to use a condom in addition to having their female partner use another form of contraception.
- Diagnosis of probable Type 2 diabetes after the age of 30 and for at least 6 months prior to the screening visit and: not requiring insulin within first year of diagnosis; no history of diabetic ketoacidosis (DKA); body mass index (BMI) of 40 or less at the screening visit
- Presence of persistent albuminuria with a UACR of 6.7 - 203 mg/mmol Must be taking the highest tolerated dose of an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB) and have been maintained on that dose for at least 3 months prior to the Baseline visit
- Blood pressure(BP) must be stable and well controlled by the judgement of the investigator (goal of the control of BP is 130/80 or less). If required, the use of anti-hypertensives in addition to an ACE inhibitor or an ARB is acceptable.
- Patients with a calculated creatinine clearance of greater than or equal to 30 mL/min and without the presence of clinically significant hematuria or red or white cell casts can be included in the study.
Who cannot join
- Diagnosis of Type 1 diabetes
- Hemoglobin A1c (HbA1c) >10%
- Females cannot be breast-feeding
- Known renal artery stenosis
- Calculated creatinine clearance <30 mL/min or the presence of clinically significant hematuria of red or white cell casts
- Chronic use of NSAIDs or more than 1 g/day of aspirin
Show all 18Show fewer
- QTc >450 msec for females or >430 msec for males (a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle)
- Known family history of prolonged QT syndrome
- History of symptomatic congestive heart failure within the last 2 years
- History of syncope in the lst 2 years or recurrent hypokalemia, including that caused by diuretics
- Myocardial infarction or signs or symptoms of unstable coronary artery disease with the last year
- Pulmonary disease or evidence of clinically significant pulmonary symptoms.
- Active neoplastic disease. (Excised cutaneous basal cell carcinomas are not excluded). Patients with stable prostate cancer may be included at the discretion of the Medical Monitor.
- Any clinically significant hematologic or coagulation disorder
- Any clinically significant hepatic disease
- Use of excluded medications: drugs known to significantly increase QTc and/or have increased risk of torsades de point, immunosuppressive agents, cancer chemotherapeutic agents, oral corticosteroids other than maintenance doses equivalent to 7.5 mg prednisone per day, and radiotherapy
- Use of an investigational drug within 30 days or within 5 half-lives of the investigational agent, whichever is longer, or use of an investigational medical device within 2 weeks before or after the study
- Any other disease or condition that, in the opinion of the investigator, makes the patient unsuitable to participate in this study
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Canada19 sites
Pfizer Investigational Site
Burlington, Ontario, L7M 4Y1
Pfizer Investigational Site
Courtice, Ontario, L1E 3C3
Pfizer Investigational Site
Fort Erie, Ontario, L2A 1Z3
Pfizer Investigational Site
Hamilton, Ontario, L8M 1K7
Pfizer Investigational Site
Kitchener, Ontario, N2G 1N9
Pfizer Investigational Site
Kitchener, Ontario, N2H 5Z8
Pfizer Investigational Site
Millon, Ontario, L9T 0H7
Pfizer Investigational Site
North Bay, Ontario, P1B 2H3
Pfizer Investigational Site
Oakville, Ontario, L6H 3P1
Pfizer Investigational Site
Penticton, British Columbia, V2A 5C8
Pfizer Investigational Site
Red Deer, Alberta, T4N 6V7
Pfizer Investigational Site
Saint Catherines, Ontario, L2N 7H8
Pfizer Investigational Site
Saskatoon, Saskatchewan, S7K 0H6
Pfizer Investigational Site
Scarborough Village, Ontario, M1H 3G4
Pfizer Investigational Site
Smith Falls, Ontario, K7A 4W8
Pfizer Investigational Site
Thornhill, Ontario, L4J 8L7
Pfizer Investigational Site
Toronto, Ontario, M4N-3M5
Pfizer Investigational Site
Toronto, Ontario, M4R 2G4
Pfizer Investigational Site
Vancouver, British Columbia, V6E 1M7
About this study
Official title: Double-Blind, Randomized, Placebo-Controlled, Phase IIa, Multicenter Study In Patients With Type 2 Diabetes And Persistent Albuminuria To Evaluate The Safety And Efficacy Of A Six Month Regimen Of Orally-Administered TTP488
Current research indicates that TTP488 may be a viable agent for the treatment of diabetic nephropathy. The purpose of this study is to determine the safety and efficacy of a six-month regimen of daily orally-administered TTP488 to patients with diabetic nephropathy.
- Conditions
- Diabetic Nephropathy
- Being tested
- PF-04494700 (TTP488), Placebo
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-04494700 (TTP488)Drug
60 mg/day for 6 days followed by 20 mg/day for 175 days vs placebo, oral medication
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| PF-04494700 (TTP488) | Active comparator | Not described Receives: Drug: PF-04494700 (TTP488) |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint of efficacy will be assessed by comparing the treatment groups based on the change in urinary albumin-creatinine ratio (UACR)
Measured: from baseline to end of treatment (Month 6).
Secondary outcomes (5)
To evaluate treatment on estimated GFR and serum creatinine
Measured: evaluated for change from baseline to months 3 & 6
To evaluate the effects of TTP488 on other relevant biomarkers
Measured: evaluated at months 1, 3 & 6
To evaluate the safety of TTP488
Measured: Ongoing
To evaluate the PK profile of oral TTP488.
Measured: Ongoing
To evaluate the effect of treatment with TTP488 on UACR
Measured: evaluated from baseline to month 3 visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionAug 2009
- Study completionAug 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 Diabetic NephropathyStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287183
- Sponsor's protocol ID
- B0341001
- Other IDs
- TTP488-202
- Status last verified
- Sep 2009
- First submitted
- 20 Jan 2006
- Last updated
- 1 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Hu S, Lee K, He JC, Fan Y. Current Landscape and Emerging Therapeutic Targets in Diabetic Kidney Disease. Clin J Am Soc Nephrol. 2026 Mar 10. doi: 10.2215/CJN.0000001053. Online ahead of print.
PubMed 41805697
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Randomized, Placebo-Controlled, Phase IIa, Multicenter Study In Patients With Type 2 Diabetes And Persistent Albuminuria To Evaluate The Safety And Efficacy Of A Six Month Regimen Of Orally-Administered TTP488
- ClinicalTrials.gov ID
- NCT00287183
- Acronym / sponsor ID
- B0341001
- Conditions
- Diabetic Nephropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 6 Feb 2006 (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.
Current research indicates that TTP488 may be a viable agent for the treatment of diabetic nephropathy. The purpose of this study is to determine the safety and efficacy of a six-month regimen of daily orally-administered TTP488 to patients with diabetic nephropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PF-04494700 (TTP488) | Active comparator | Drug: PF-04494700 (TTP488) |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 31 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female outpatients 31 years of age or older.
- Females must no longer be of child-bearing potential, must have a negative serum pregnancy test, and cannot be breast-feeding.
- Non-vasectomized male must be willing to abstain from sexual intercourse or willing to use a condom in addition to having their female partner use another form of contraception.
- Diagnosis of probable Type 2 diabetes after the age of 30 and for at least 6 months prior to the screening visit and: not requiring insulin within first year of diagnosis; no history of diabetic ketoacidosis (DKA); body mass index (BMI) of 40 or less at the screening visit
- Presence of persistent albuminuria with a UACR of 6.7 - 203 mg/mmol Must be taking the highest tolerated dose of an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB) and have been maintained on that dose for at least 3 months prior to the Baseline visit
Key exclusion criteria (18 listed)
- Diagnosis of Type 1 diabetes
- Hemoglobin A1c (HbA1c) >10%
- Females cannot be breast-feeding
- Known renal artery stenosis
- Calculated creatinine clearance <30 mL/min or the presence of clinically significant hematuria of red or white cell casts
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 |
|---|---|---|
| PF-04494700 (TTP488)60 mg/day for 6 days followed by 20 mg/day for 175 days vs placebo, oral medication | Drug | PF-04494700 (TTP488) |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Primary endpoint of efficacy will be assessed by comparing the treatment groups based on the change in urinary albumin-creatinine ratio (UACR)
Time frame: from baseline to end of treatment (Month 6).
5 secondary outcomes
To evaluate treatment on estimated GFR and serum creatinine
Time frame: evaluated for change from baseline to months 3 & 6
To evaluate the effects of TTP488 on other relevant biomarkers
Time frame: evaluated at months 1, 3 & 6
To evaluate the safety of TTP488
Time frame: Ongoing
To evaluate the PK profile of oral TTP488.
Time frame: Ongoing
To evaluate the effect of treatment with TTP488 on UACR
Time frame: evaluated from baseline to month 3 visit
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 1 Oct 2009.
- Derived from this study: PubMed 41805697Hu S, Lee K, He JC, Fan Y. Current Landscape and Emerging Therapeutic Targets in Diabetic Kidney Disease. Clin J Am Soc Nephrol. 2026 Mar 10. doi: 10.2215/CJN.0000001053. Online ahead of print.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PF-04494700 (TTP488) in people with Diabetic Nephropathy, run by Pfizer at 19 sites in Canada.
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 18 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 1 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Canada. 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?
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?
Primary endpoint of efficacy will be assessed by comparing the treatment groups based on the change in urinary albumin-creatinine ratio (UACR) (time frame: from baseline to end of treatment (Month 6).). 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 NCT00287183, 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 1 Oct 2009.