Trial Outcomes & Findings for Tacrolimus Versus Prednisolone for the Treatment of Minimal Change Disease (NCT NCT00982072)

NCT ID: NCT00982072

Last Updated: 2021-05-04

Results Overview

normalisation of serum albumin and urine PCR \<50 units

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 52 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2021-05-04

Participant Flow

Participant milestones

Measure	Prednisolone prednisolone tablets prednisolone: Prednisolone 1mg/kg maximum 60mg od	Tacrolimus tacrolimus tablets tacrolimus: tacrolimus0.05mg/kg bd (levels 6-12ng/ml)
Overall Study STARTED	25	27
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Prednisolone n=25 Participants prednisolone tablets prednisolone: Prednisolone 1mg/kg maximum 60mg od	Tacrolimus n=27 Participants tacrolimus tablets tacrolimus: tacrolimus0.05mg/kg bd (levels 6-12ng/ml)	Total n=52 Participants Total of all reporting groups
Age, Customized 18 years and over	25 Participants n=25 Participants	27 Participants n=27 Participants	52 Participants n=52 Participants
Sex: Female, Male Female	10 Participants n=25 Participants	15 Participants n=27 Participants	25 Participants n=52 Participants
Sex: Female, Male Male	15 Participants n=25 Participants	12 Participants n=27 Participants	27 Participants n=52 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	25 participants n=25 Participants	27 participants n=27 Participants	52 participants n=52 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Patients at 8 weeks of therapy- on intention to treat basis

normalisation of serum albumin and urine PCR <50 units

Outcome measures

Measure	Prednisolone n=25 Participants prednisolone tablets prednisolone: Prednisolone 1mg/kg maximum 60mg od	Tacrolimus n=27 Participants tacrolimus tablets tacrolimus: tacrolimus0.05mg/kg bd (levels 6-12ng/ml)
Percentage of Participants Achieving Complete Remission From Nephrotic Syndrome at 8 Weeks	21 Participants	17 Participants

SECONDARY outcome

Timeframe: 16 and 26 weeks

Population: Patients on intention to treat basis

Outcome measures

Measure	Prednisolone n=25 Participants prednisolone tablets prednisolone: Prednisolone 1mg/kg maximum 60mg od	Tacrolimus n=27 Participants tacrolimus tablets tacrolimus: tacrolimus0.05mg/kg bd (levels 6-12ng/ml)
Percentage of Patients Achieving Complete Remission From Nephrotic Syndrome at 16 and 26 Weeks 16 weeks	23 Participants	19 Participants
Percentage of Patients Achieving Complete Remission From Nephrotic Syndrome at 16 and 26 Weeks 26 weeks	23 Participants	22 Participants

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Measure	Prednisolone n=23 Participants prednisolone tablets prednisolone: Prednisolone 1mg/kg maximum 60mg od	Tacrolimus n=22 Participants tacrolimus tablets tacrolimus: tacrolimus0.05mg/kg bd (levels 6-12ng/ml)
Percentage of Patients Achieving Remission Who Then Relapse	17 Participants	16 Participants

SECONDARY outcome

Timeframe: 3 years

Outcome measures

Measure	Prednisolone n=25 Participants prednisolone tablets prednisolone: Prednisolone 1mg/kg maximum 60mg od	Tacrolimus n=27 Participants tacrolimus tablets tacrolimus: tacrolimus0.05mg/kg bd (levels 6-12ng/ml)
Number of Serious Adverse Events	4 serious adverse events	3 serious adverse events

SECONDARY outcome

Timeframe: 3 years

Population: data not collected

Outcome measures

Outcome data not reported

Adverse Events

Prednisolone

Serious events: 4 serious events

Other events: 18 other events

Deaths: 0 deaths

Tacrolimus

Serious events: 3 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	Prednisolone n=25 participants at risk prednisolone tablets prednisolone: Prednisolone 1mg/kg maximum 60mg od	Tacrolimus n=27 participants at risk tacrolimus tablets tacrolimus: tacrolimus0.05mg/kg bd (levels 6-12ng/ml)
Gastrointestinal disorders diverticualr disease	4.0% 1/25 • Number of events 1 • Up to 3 years	0.00% 0/27 • Up to 3 years
Nervous system disorders headache	4.0% 1/25 • Number of events 1 • Up to 3 years	0.00% 0/27 • Up to 3 years
Musculoskeletal and connective tissue disorders fracture radius	4.0% 1/25 • Number of events 1 • Up to 3 years	0.00% 0/27 • Up to 3 years
Respiratory, thoracic and mediastinal disorders respiratory infection	4.0% 1/25 • Number of events 1 • Up to 3 years	3.7% 1/27 • Number of events 1 • Up to 3 years
Cardiac disorders hypertension	0.00% 0/25 • Up to 3 years	3.7% 1/27 • Number of events 1 • Up to 3 years
Skin and subcutaneous tissue disorders rash and diarhoaea	0.00% 0/25 • Up to 3 years	3.7% 1/27 • Number of events 1 • Up to 3 years

Other adverse events

Measure	Prednisolone n=25 participants at risk prednisolone tablets prednisolone: Prednisolone 1mg/kg maximum 60mg od	Tacrolimus n=27 participants at risk tacrolimus tablets tacrolimus: tacrolimus0.05mg/kg bd (levels 6-12ng/ml)
General disorders various non serious	72.0% 18/25 • Number of events 18 • Up to 3 years	74.1% 20/27 • Number of events 20 • Up to 3 years

Additional Information

Dr Megan Griffith

Imperial College NHS Trust

Phone: 02033137309

Email: m.e.griffith@imperial.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place