Status:
COMPLETED
Tacrolimus Versus Prednisolone for the Treatment of Minimal Change Disease
Lead Sponsor:
Imperial College Healthcare NHS Trust
Conditions:
Minimal Change Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the effectiveness of tacrolimus (prograf) versus prednisolone for the treatment of nephrotic syndrome secondary to minimal change disease.
Detailed Description
Minimal change disease is a common cause of nephrotic syndrome in adults. Standard treatment is with high dose steroids which is often effective in controlling the nephrotic syndrome but has a high mo...
Eligibility Criteria
Inclusion
- Patients with nephrotic syndrome (hypoalbuminaemia and protein creatinine ratio (PCR) \> 100units), secondary to minimal change disease.
- Age over 18.
Exclusion
- Hepatitis B, hepatitis C or HIV infection.
- Untreated infection.
- Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception.
- Patients who have been treated with immunosuppression over the last 18 months.
- Patients who have had more than 3 relapses of nephrotic syndrome within 5 years.
- Any condition judged by the investigator that would cause the study to be detrimental to the patient.
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2019
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00982072
Start Date
December 1 2009
End Date
October 10 2019
Last Update
May 4 2021
Active Locations (1)
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1
Hammersmith Hospital
London, United Kingdom, W12 OHS