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TerminatedNCT00120328Updated Oct 5, 2007

To Determine the Effects of Avosentan on Doubling of Serum Creatinine, End Stage Renal Disease and Death in Diabetic Nephropathy

A Phase 3 interventional study of SPP301 in Diabetic Nephropathy, sponsored by Speedel Pharma Ltd.. Terminated at 1 site in United States. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2007-10-05.

Sponsored by Speedel Pharma Ltd. · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
2,364
Allocation
Randomized
Ages
21 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Diabetic Nephropathy

Keywords

  • serum creatinine
  • end stage renal disease
  • cardiovascular mortality
  • cardiovascular morbidity
  • non-cardiovascular mortality
  • non-cardiovascular morbidity
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 2,364 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Speedel Pharma Ltd. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
2,364 participants

Interventions

  • DrugSPP301
06

What researchers measure

Primary outcomes

  1. 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

  1. To determine the effect of each dose of avosentan on: cardiovascular mortality

  2. non-cardiovascular mortality

  3. coronary or peripheral vascular revascularisations including amputations (except where due to trauma)

  4. non-fatal acute myocardial infarction

  5. stroke

  6. congestive heart failure

  7. unstable angina

07

Study locations

1 site
  • Dr. Mark Warren
    Greenville, North Carolina 27834, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00120328
Lead sponsor
Speedel Pharma Ltd.
First posted
Jul 15, 2005
Start date
Jul 2005
Completion
Feb 2007
Last update
Oct 5, 2007

Study contacts

Jessica Mann, MD, PhD
study director · Speedel Pharma Ltd.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.

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