Diabetic NephropathyPhase 3NCT00120328
To Determine the Effects of Avosentan on Doubling of Serum Creatinine, End Stage Renal Disease and Death in Diabetic Nephropathy
A Phase 3 study testing SPP301 in people with Diabetic Nephropathy, run by Speedel Pharma Ltd. at 1 site in United States.
Trial summary
The purpose of this study is to determine whether avosentan (SPP301) is effective in decreasing morbidity and mortality in patients with diabetic nephropathy. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Diabetic Nephropathy
- What is being tested?
- SPP301
- How many people
- 2,364 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Feb 2007
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients between 21 and 80 years of age, inclusive
- Patients with type 2 diabetes mellitus diagnosed for at least 3 years and receiving oral anti-diabetic treatment and/or insulin
- Female patients will either be:
- Post menopausal for >= 2 years;
- Surgically sterile;
- Or, if sexually active and of childbearing potential, using double contraception, with at least one method being barrier contraception. Women of childbearing potential (defined as those who are not surgically sterile, have not had a hysterectomy or are not 2 years' post-menopausal) must have a negative pregnancy test at screening and at randomisation. Pregnancy tests will be repeated monthly during the study
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- Proteinuria defined as ACR >= 35mg/mmol
- Male patients with serum creatinine between 1.3 and 3.0 mg/dL
- Female patients with serum creatinine between 1.2 and 3.0 mg/dL
- On standard treatment for diabetic nephropathy (such as ACE inhibitors, ARBs or the combination thereof) for at least 6 months before screening. Patients who are intolerant to ACE inhibitors or ARBs will be allowed to enter the study
- Able to provide written informed consent prior to study participation
Who cannot join
- Patients with type 1 diabetes mellitus
- Patients with proteinuria of non-diabetic origin
- Patients with a renal transplant
- Patients who have undergone nephrectomy
- Patients with an estimated GFR <= 15 mL/min
- Patients with blood pressure >= 160/100 mmHg with or without antihypertensive medication
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- Patients with glycosylated haemoglobin (HbA1c) > 12%
- Patients with normal sinus rhythm who do not have a pacemaker, are not taking antiarrhythmic drugs and do not have complete bundle branch block, but who have absolute QT or QTc >500 msec
- Patients with recent (60 days) percutaneous transluminal coronary angioplasty (PTCA), percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), or any other major surgical intervention
- Patients with recent (60 days) acute myocardial infarction, unstable angina, stroke or transient ischaemic attack
- Patients with CHF New York Heart Association grade III or IV
- Patients with life-threatening arrhythmias including those at high risk for QT/QTc prolongation such as a family history of Long QT Syndrome, severe hypokalaemia, etc.
- Patients who are positive for hepatitis B surface antigen or hepatitis C antibody at Visit 1 (screening) and who have abnormal liver function (specifically ALAT/ASAT >1 x ULN)
- Patients who have been treated with an endothelin receptor antagonist in the 3 months prior to screening
- Patients being treated with spironolactone or eplerenone at entry into the study
- Pregnant or lactating women
- Patients with a neoplasm who are deemed to live < 12 months
- Patients with history of alcohol and/or drug abuse
- Patients with a known history of a major psychiatric condition that would interfere with the conduct of the trial
- Patients with active endocarditis and/or pericarditis
- Patients allergic to avosentan or any other endothelin receptor antagonist
- Patients who participated in another clinical study or who have donated blood within 60 days of being randomised to this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ASCEND - A Randomised, Double Blind, Placebo Controlled, Parallel Group Study to Assess the Effect of the Endothelin Receptor Antagonist Avosentan on Time to Doubling of Serum Creatinine, End Stage Renal Disease or Death in Patients With Type 2 Diabetes Mellitus and Diabetic Nephropathy
The purpose of this study is to determine whether avosentan (SPP301) is effective in decreasing morbidity and mortality in patients with diabetic nephropathy.
Read the detailed description
Diabetic nephropathy has become the leading cause of end stage renal disease (ESRD) in the western world, accounting for approximately 40% of new cases in the US, and up to 20 to 30% in Europe.
Current treatments for diabetic nephropathy usually try to deal with the underlying diabetes or they aim to reduce cardiovascular risk factors such as hypertension, hyperglycemia, smoking and dyslipidemia. A few recently approved drugs such as irbesartan and losartan (for type 2 diabetic nephropathy) have a renoprotective activity beyond their antihypertensive effect. However, morbidity and mortality rates remain high.
Avosentan may have a positive effect on reducing the amount of protein lost in the urine and if this is the case it will help treat patients with diabetic nephropathy.
- Conditions
- Diabetic Nephropathy
- Being tested
- SPP301
- Keywords
- serum creatinine, end stage renal disease, cardiovascular mortality, cardiovascular morbidity, non-cardiovascular mortality, non-cardiovascular morbidity
- Medical subject headings
- Diabetic Nephropathies, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPP301Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effect of each dose of avosentan on time to doubling of serum creatinine, end stage renal disease (ESRD) or death when administered on top of standard treatment in subjects with type 2 diabetes mellitus and diabetic nephropathy.
Secondary outcomes (7)
To determine the effect of each dose of avosentan on: cardiovascular mortality
non-cardiovascular mortality
coronary or peripheral vascular revascularisations including amputations (except where due to trauma)
non-fatal acute myocardial infarction
stroke
congestive heart failure
unstable angina
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2005 (estimated)
- Study startJul 2005
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathyStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 2,364 participants
Sponsor and investigators
- Lead sponsor
- Speedel Pharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jessica Mann, MD, PhD, Study director, Speedel Pharma Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00120328
- Sponsor's protocol ID
- SPP301CRD15
- Other IDs
- 2005-000604-14, 2005
- Status last verified
- Oct 2007
- First submitted
- 30 Jun 2005
- Last updated
- 5 Oct 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASCEND - A Randomised, Double Blind, Placebo Controlled, Parallel Group Study to Assess the Effect of the Endothelin Receptor Antagonist Avosentan on Time to Doubling of Serum Creatinine, End Stage Renal Disease or Death in Patients With Type 2 Diabetes Mellitus and Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT00120328
- Acronym / sponsor ID
- SPP301CRD15
- Conditions
- Diabetic Nephropathy
- Keywords
- serum creatinine, end stage renal disease, cardiovascular mortality, cardiovascular morbidity, non-cardiovascular mortality, non-cardiovascular morbidity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 2,364 participants
- Lead sponsor
- Speedel Pharma Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2005
- Study completion
- Feb 2007 (actual)
- First posted
- 15 Jul 2005 (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 avosentan (SPP301) is effective in decreasing morbidity and mortality in patients with diabetic nephropathy.
Detailed description
Diabetic nephropathy has become the leading cause of end stage renal disease (ESRD) in the western world, accounting for approximately 40% of new cases in the US, and up to 20 to 30% in Europe.
Current treatments for diabetic nephropathy usually try to deal with the underlying diabetes or they aim to reduce cardiovascular risk factors such as hypertension, hyperglycemia, smoking and dyslipidemia. A few recently approved drugs such as irbesartan and losartan (for type 2 diabetic nephropathy) have a renoprotective activity beyond their antihypertensive effect. However, morbidity and mortality rates remain high.
Avosentan may have a positive effect on reducing the amount of protein lost in the urine and if this is the case it will help treat patients with diabetic nephropathy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female patients between 21 and 80 years of age, inclusive
- Patients with type 2 diabetes mellitus diagnosed for at least 3 years and receiving oral anti-diabetic treatment and/or insulin
- Female patients will either be:
- Proteinuria defined as ACR >= 35mg/mmol
- Male patients with serum creatinine between 1.3 and 3.0 mg/dL
Key exclusion criteria (22 listed)
- Patients with type 1 diabetes mellitus
- Patients with proteinuria of non-diabetic origin
- Patients with a renal transplant
- Patients who have undergone nephrectomy
- Patients with an estimated GFR <= 15 mL/min
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 |
|---|---|---|
| SPP301 | Drug | – |
Primary outcome
To determine the effect of each dose of avosentan on time to doubling of serum creatinine, end stage renal disease (ESRD) or death when administered on top of standard treatment in subjects with type 2 diabetes mellitus and diabetic nephropathy.
7 secondary outcomes
To determine the effect of each dose of avosentan on: cardiovascular mortality
non-cardiovascular mortality
coronary or peripheral vascular revascularisations including amputations (except where due to trauma)
non-fatal acute myocardial infarction
stroke
congestive heart failure
unstable angina
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2007.
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Pentoxifylline in Diabetic Kidney Disease
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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.
Jessica Mann, MD, PhD study director
Speedel Pharma Ltd.
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 SPP301 in people with Diabetic Nephropathy, run by Speedel Pharma Ltd. at 1 site 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 11 inclusion and 22 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: stopped early, as of the sponsor's last update on 5 Oct 2007. 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. 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 was stopped early. Results are not available in the source record.
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?
To determine the effect of each dose of avosentan on time to doubling of serum creatinine, end stage renal disease (ESRD) or death when administered on top of standard treatment in subjects with type 2 diabetes mellitus and diabetic nephropathy.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2007.