Phase 4
N=52
Tacrolimus Versus Prednisolone for the Treatment of Minimal Change Disease
Minimal Change Disease
Bottom Line
View on ClinicalTrials.gov: NCT00982072 ↗Enrolled (actual)
52
Serious AEs
13.5%
Results posted
May 2021
Primary outcome: Primary: Percentage of Participants Achieving Complete Remission From Nephrotic Syndrome at 8 Weeks — 21; 17 Participants — p=0.12
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- tacrolimus (Drug); prednisolone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College Healthcare NHS Trust
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Complete Remission From Nephrotic Syndrome at 8 Weeks |
21; 17 | 0.12 |
| SECONDARY Percentage of Patients Achieving Complete Remission From Nephrotic Syndrome at 16 and 26 Weeks |
23; 19; 23; 22 | — |
| SECONDARY Percentage of Patients Achieving Remission Who Then Relapse |
17; 16 | — |
| SECONDARY Number of Serious Adverse Events |
4; 3 | — |
| SECONDARY Change in Baseline Glomerular Filtration Rate |
— | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00982072). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.