Trial Outcomes & Findings for Mycophenolate Mofetil and Tacrolimus Versus Tacrolimus for the Treatment of Idiopathic Membranous Glomerulonephritis (NCT NCT00843856)

NCT ID: NCT00843856

Last Updated: 2019-12-12

Results Overview

Efficacy of mycophenolate in preventing relapse of nephrotic syndrome secondary to membranous glomerulonephritis on withdrawal of tacrolimus therapy.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 40 participants
• Primary outcome timeframe: 10-109 weeks
• Results posted on: 2019-12-12

Participant Flow

Participant milestones

Measure	Tacrolimus Intervention type -drug tacrolimus therapy 2mg bd adjust to obtain levels of 5-12ng/L tacrolimus: tacrolimus 2mgs bd adjusted to obtain levels of 5-12ng/ml	Tacrolimus and Mycophenolate Mofetil tacrolimus 2mgs bd (adjusted to obtain levels 5-12mg/L and mycophenolate mofetil 500mg bd adjusted to obtain levels 1.5-3mg/L tacrolimus and mycophenolate mofetil: tacrolimus 2mg bd adjusted to achieve levels of 5-12ng/L mycophenolate mofetil 500mgs bd adjusted to achieve levels of 1.5-3mg/L
Overall Study STARTED	20	20
Overall Study COMPLETED	19	18
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Measure	Tacrolimus Intervention type -drug tacrolimus therapy 2mg bd adjust to obtain levels of 5-12ng/L tacrolimus: tacrolimus 2mgs bd adjusted to obtain levels of 5-12ng/ml	Tacrolimus and Mycophenolate Mofetil tacrolimus 2mgs bd (adjusted to obtain levels 5-12mg/L and mycophenolate mofetil 500mg bd adjusted to obtain levels 1.5-3mg/L tacrolimus and mycophenolate mofetil: tacrolimus 2mg bd adjusted to achieve levels of 5-12ng/L mycophenolate mofetil 500mgs bd adjusted to achieve levels of 1.5-3mg/L
Overall Study Lost to Follow-up	1	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Tacrolimus n=20 Participants Intervention type -drug tacrolimus therapy 2mg bd adjust to obtain levels of 5-12ng/L tacrolimus: tacrolimus 2mgs bd adjusted to obtain levels of 5-12ng/ml	Tacrolimus and Mycophenolate Mofetil n=20 Participants tacrolimus 2mgs bd (adjusted to obtain levels 5-12mg/L and mycophenolate mofetil 500mg bd adjusted to obtain levels 1.5-3mg/L tacrolimus and mycophenolate mofetil: tacrolimus 2mg bd adjusted to achieve levels of 5-12ng/L mycophenolate mofetil 500mgs bd adjusted to achieve levels of 1.5-3mg/L	Total n=40 Participants Total of all reporting groups
Age, Continuous	55 years n=20 Participants	48 years n=20 Participants	51 years n=40 Participants
Sex: Female, Male Female	9 Participants n=20 Participants	7 Participants n=20 Participants	16 Participants n=40 Participants
Sex: Female, Male Male	11 Participants n=20 Participants	13 Participants n=20 Participants	24 Participants n=40 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	20 participants n=20 Participants	20 participants n=20 Participants	40 participants n=40 Participants
Serum albumin	17 g/L n=20 Participants	18 g/L n=20 Participants	17.5 g/L n=40 Participants
Estimated glomerus filtration rate (GRF)	109 mls/min/1.73m^2 n=20 Participants	121 mls/min/1.73m^2 n=20 Participants	115 mls/min/1.73m^2 n=40 Participants

PRIMARY outcome

Timeframe: 10-109 weeks

Efficacy of mycophenolate in preventing relapse of nephrotic syndrome secondary to membranous glomerulonephritis on withdrawal of tacrolimus therapy.

Outcome measures

Measure	Tacrolimus n=16 Participants Intervention type -drug tacrolimus therapy 2mg bd adjust to obtain levels of 5-12ng/L tacrolimus: tacrolimus 2mgs bd adjusted to obtain levels of 5-12ng/ml	Tacrolimus and Mycophenolate Mofetil n=19 Participants tacrolimus 2mgs bd (adjusted to obtain levels 5-12mg/L and mycophenolate mofetil 500mg bd adjusted to obtain levels 1.5-3mg/L tacrolimus and mycophenolate mofetil: tacrolimus 2mg bd adjusted to achieve levels of 5-12ng/L mycophenolate mofetil 500mgs bd adjusted to achieve levels of 1.5-3mg/L
Number of Patient Who Gained Remission From the Nephrotic Syndrome	8 Participants	8 Participants

SECONDARY outcome

Timeframe: 6-12 months

The degree of remission of proteinuria obtained (complete or partial) The rate of decline of renal function measured by the Modification of Diet in Renal Disease equation for glomerular filtration rate.

Outcome measures

Measure	Tacrolimus n=20 Participants Intervention type -drug tacrolimus therapy 2mg bd adjust to obtain levels of 5-12ng/L tacrolimus: tacrolimus 2mgs bd adjusted to obtain levels of 5-12ng/ml	Tacrolimus and Mycophenolate Mofetil n=20 Participants tacrolimus 2mgs bd (adjusted to obtain levels 5-12mg/L and mycophenolate mofetil 500mg bd adjusted to obtain levels 1.5-3mg/L tacrolimus and mycophenolate mofetil: tacrolimus 2mg bd adjusted to achieve levels of 5-12ng/L mycophenolate mofetil 500mgs bd adjusted to achieve levels of 1.5-3mg/L
Number of Patients Achieved Remission	16 Participants	19 Participants

Adverse Events

Tacrolimus

Serious events: 7 serious events

Other events: 0 other events

Deaths: 0 deaths

Tacrolimus and Mycophenolate Mofetil

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tacrolimus n=20 participants at risk Intervention type -drug tacrolimus therapy 2mg bd adjust to obtain levels of 5-12ng/L tacrolimus: tacrolimus 2mgs bd adjusted to obtain levels of 5-12ng/ml	Tacrolimus and Mycophenolate Mofetil n=20 participants at risk tacrolimus 2mgs bd (adjusted to obtain levels 5-12mg/L and mycophenolate mofetil 500mg bd adjusted to obtain levels 1.5-3mg/L tacrolimus and mycophenolate mofetil: tacrolimus 2mg bd adjusted to achieve levels of 5-12ng/L mycophenolate mofetil 500mgs bd adjusted to achieve levels of 1.5-3mg/L
Gastrointestinal disorders diarrhoe and vomiting	15.0% 3/20 • Number of events 3 • 9.5 years	10.0% 2/20 • Number of events 2 • 9.5 years
Blood and lymphatic system disorders Anemia	0.00% 0/20 • 9.5 years	10.0% 2/20 • Number of events 2 • 9.5 years
Blood and lymphatic system disorders Haemorrhoidectomy	0.00% 0/20 • 9.5 years	5.0% 1/20 • Number of events 1 • 9.5 years
Renal and urinary disorders Acute kidney injury	15.0% 3/20 • Number of events 3 • 9.5 years	0.00% 0/20 • 9.5 years
Nervous system disorders Headache	5.0% 1/20 • Number of events 1 • 9.5 years	0.00% 0/20 • 9.5 years
Infections and infestations Infection	5.0% 1/20 • Number of events 1 • 9.5 years	0.00% 0/20 • 9.5 years
Metabolism and nutrition disorders Cholestatic jaundice	0.00% 0/20 • 9.5 years	5.0% 1/20 • Number of events 1 • 9.5 years
Renal and urinary disorders Haematuria	10.0% 2/20 • Number of events 2 • 9.5 years	0.00% 0/20 • 9.5 years

Other adverse events

Adverse event data not reported

Additional Information

Dr Megan Griffith

Imperial College NHS Trust

Phone: 02083835272

Email: megan.griffith1@nhs.net

Results disclosure agreements

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