Tacrolimus vs prednisolone for the treatment of nephrotic syndrome secondary to minimal change disease: A Randomised Control Trial - Tacrolimus vs prednisolone for minimal change disease

Phase 1

• Conditions: ephrotic syndrome with lesion minimal change glomerulonephritis; MedDRA version: 05 Level: LLT Classification code 10029167 Term: nephrotic syndrome secondary with lesion of minimal change glomerulonephritis

• Registration Number: EUCTR2009-014292-52-GB
• Lead Sponsor: Imperial College NHS trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-08-04
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 52

Inclusion Criteria

Patients presenting to participating hospital renal clinics with nephrotic syndrome (hypoalbuminaemia and protein creatinine ratio(PCR) >100units), secondary to minimal change disease.
Age over 18.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Hepatitis B, hepatitis C or HIV infection
2.Untreated infection
3.Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception.
4. Patients who have been treated with immunosuppression over the last 18 months.
5. Patients who have had more than 3 relapses of nephrotic syndrome within 5 years
6. Any condition judged by the investigator that would cause the study to be detrimental to the patient

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the effectiveness of tacrolimus versus prednisolone for the treatment of nephrotic syndrome ((hypoalbuminaemia and urine protein/creatinine ratio (PCR) > 100units)) secondary to minimal change disease. The effectiveness of each treatment will be compared by the initial response rate (the proportion of patients achieving complete remission from nephrotic syndrome). ;Secondary Objective: The effectiveness of each treatment will also be compared by the time taken to achieve complete remission, and the relapse rate post withdrawal of therapy, and the frequency, nature and severity of the side effects.;<br> Primary end point(s): Proportion of patients achieving complete remission from nephrotic syndrome (normalisation of serum albumin and urine PCR <50 units) at 8 weeks.<br><br>