Site reviewed:
June 2008
A clinical study of Tolvaptan, named TEMPO (Tolvaptan Efficacy and safety in Management of Polycystic kidney disease and its Outcomes) has begun in the UK.
Tolvaptan is being evaluated as a potential treatment for PKD after its efficacy was demonstrated on studies with rats with polycystic kidneys.
The following hospitals are taking part and are starting to enrol patients. The name of the lead investigator is shown alongside.
King’s College Hospital, London -
Brighton & Sussex University Hospitals, Royal Sussex County Hospital -
Queen Elizabeth Hospital, Birmingham -
University Hospital Coventry and Warwickshire, Coventry -
Raigmore Hospital, Inverness -
If you don’t live near any of these hospitals, and you think you may be eligible, ask your GP or renal consultant to contact the lead investigator for a referral.
You can also find out more by visiting the international TEMPO trial study site.
The criteria for the trial are:
Aged 18 to 50 years
Men and women
Inclusion Criteria:
- GFR estimated at ≥60 mL/ min/ 1.73m2
- Diagnosis of ADPKD and rapidly progressive kidney growth (total volume ≥750 cc) by Magnetic Resonance Imaging (MRI) at randomization
- Legal adult age and able to give Informed Consent
- Willingness to comply with reproductive precautions if female
Exclusion Criteria:
- Prior exposure to tolvaptan or other experimental PKD therapies
- Currently taking medication for purpose of affecting PKD cysts
- Women who are breast feeding and females of childbearing potential who are not using acceptable contraceptive methods
- In the opinion of the study investigator or sponsor may present a safety risk or confound study objectives
- Patients who are unlikely to adequately comply with study procedures
- Patients having contraindications to MRI
For PKD patients in the UK this study is encouraging. However, it must be stressed that, while results in rodent tests are promising, many potential ‘wonder’ drug fail subsequent stages of the research process.
Updated May 2008