The IMPACT SHPT Study

• Research type

  Research Study

• Full title

  The IMPACT SHPT Study: Study to evaluate the improved management of iPTH with Paricalcitol-centered therapy vs. Cinacalcet therapy with low-dose vitamin D in hemodialysis patients with secondary hyperparathyroidism

• IRAS ID

  26182

• Sponsor organisation

  Abbott GmbH & Co. KG

• Eudract number

  2009-011378-14

• ISRCTN Number

  N/A

• Research summary

  People who have chronic kidney disease (CKD) commonly present with a complication known as secondary hyperparathyroidism (SHPT), this is due to the over production of the parathyroid hormone (PTH). Active vitamin D is made by the kidneys and is required to maintain healthy bones and teeth, for the utilisation and absorption of calcium and phosphorous in the body. People with CKD are unable to make active vitamin D, which results in a low level of active vitamin D in the body. This subsequently causes a fall in calcium levels leading to an increased production of PTH. An increase in PTH causes the parathyroid glands to become enlarged leading to SHPT. Giving patients active vitamin D in the form of a medication can help to correct this abnormality. There are currently a number of drug treatment options which have been licensed in the UK for the treatment of SHPT. The aim of this study is to compare two of these treatments options to each other. It is hoped that the data obtained from this comparison will provide clinicians with the information for the process of determining the optimal approach to SHPT management. Patients who have stage 5 CKD on haemodialysis (a method used to remove toxic substances from the body when a person has renal failure) and who have SHPT will be eligible to participate in the study. Patients will attend regular study visits at their hospital. The effects of the study drug will be assessed at each visit by means of observing vital signs, weight and blood testing. There will be a two week screening period, a four week washout period (if required), a 28 week treatment period and a follow up phone call. This is an open label study, the study doctor and the patient will know which medication they are being treated with.

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  09/H1211/85

• Date of REC Opinion

  12 Oct 2009

• REC opinion

  Favourable Opinion