Tacrolimus Versus Prednisolone for the Treatment of Minimal Change Disease
MinTAC
Tacrolimus vs Prednisolone for the Treatment Minimal Change Disease
2 other identifiers
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2009
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2009
CompletedFirst Posted
Study publicly available on registry
September 22, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2019
CompletedResults Posted
Study results publicly available
May 4, 2021
CompletedMay 4, 2021
April 1, 2021
9.9 years
September 21, 2009
March 16, 2021
April 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Complete Remission From Nephrotic Syndrome at 8 Weeks
normalisation of serum albumin and urine PCR \<50 units
8 weeks
Secondary Outcomes (4)
Percentage of Patients Achieving Complete Remission From Nephrotic Syndrome at 16 and 26 Weeks
16 and 26 weeks
Percentage of Patients Achieving Remission Who Then Relapse
2 years
Number of Serious Adverse Events
3 years
Change in Baseline Glomerular Filtration Rate
3 years
Study Arms (2)
prednisolone
ACTIVE COMPARATORprednisolone tablets
tacrolimus
EXPERIMENTALtacrolimus tablets
Interventions
Eligibility Criteria
You may qualify if:
- Patients with nephrotic syndrome (hypoalbuminaemia and protein creatinine ratio (PCR) \> 100units), secondary to minimal change disease.
- Age over 18.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hammersmith Hospital
London, W12 OHS, United Kingdom
Related Publications (1)
Azukaitis K, Palmer SC, Strippoli GF, Hodson EM. Interventions for minimal change disease in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2022 Mar 1;3(3):CD001537. doi: 10.1002/14651858.CD001537.pub5.
PMID: 35230699DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Megan Griffith
- Organization
- Imperial College NHS Trust
Study Officials
- STUDY CHAIR
Megan Griffith, MBChBPhDFRCP
Imperial College NHS Trust
- PRINCIPAL INVESTIGATOR
Tom Cairns, MBBSMRCP
Imperial College NHS Trust
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2009
First Posted
September 22, 2009
Study Start
December 1, 2009
Primary Completion
October 10, 2019
Study Completion
October 10, 2019
Last Updated
May 4, 2021
Results First Posted
May 4, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share