Altace (ramipril) is an approved treatment, developed and marketed by Pfizer, for high blood pressure (hypertension), and to prevent related heart and kidney damage. It is currently being studied as a potential treatment of kidney failure in people with Alport syndrome.
How Altace works
Altace is an angiotensin-converting enzyme (ACE) inhibitor. ACE is responsible for the production of a molecule called angiotensin 2, which causes most arteries, including the arteries of the heart and kidneys, to contract and narrow, causing blood pressure to rise.
ACE inhibitors, such as Altace, reduce the production of angiotensin 2, relaxing and enlarging arteries, and lowering blood pressure.
In Alport syndrome, Altace is thought to protect a patient’s kidneys mainly by lowering the glomerular filtration pressure and blocking the local angiotensin-system at podocytes, a group of highly specialized cells in the kidneys. These actions result in a reduction in proteinuria (the presence of excessive amounts of protein in the urine), and excessive kidney fibrosis (the formation of hardened and scarred tissue) to protecting the kidneys.
Altace in clinical trials
Preclinical studies showed that early treatment with Altace slowed kidney failure enough to double the lifespan of mice in a model of Alport syndrome, suggesting that the treatment could also benefit people with this disease.
Retrospective observational data also demonstrated that other ACE inhibitors reduced proteinuria and delayed end-stage renal failure in Alport syndrome patients, improving their life expectancy.
These results encouraged investigators to study Altace in clinical trials for Alport syndrome.
The EARLY PRO-TECT Phase 3 trial (NCT01485978) is the result of a collaboration between the German Federal Ministry of Education and Research (BMBF) and the University Medical Center Goettingen, where the study is underway. It recruited children ages 24 months to 18 years with Alport syndrome to investigate the safety and effectiveness of Altace in slowing disease progression. Patients are being followed for three to five and a half years, and the trial is expected to finish in August 2019.
An ongoing observational study (NCT02378805) is also under the sponsorship of the University Hospital Goettingen. This study is collecting data on three generations of Alport syndrome families from the European Alport Registry, and is investigating whether Altace can delay the time to dialysis and improve life expectancy in Alport syndrome patients.
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