Tacrolimus Versus Prednisolone for the Treatment of Minimal Change Disease

Launched by IMPERIAL COLLEGE HEALTHCARE NHS TRUST · Sep 21, 2009

Keywords

ClinConnect Summary

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 morbidity due to the side effects of the steroids. There is also a high relapse rate,therefore many patients require long term steroid therapy to control their disease which has significant morbidity and mortality. Some patients are or also become steroid resistant. There are studies showing the effectiveness of alkylating agents such as cyclophosphamide but the use of these drugs is limited by t...

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Eligibility criteria

• Inclusion Criteria:
• • Patients with nephrotic syndrome (hypoalbuminaemia and protein creatinine ratio (PCR) \> 100units), secondary to minimal change disease.
• • Age over 18.
• Exclusion Criteria:
• • 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.