Trial Outcomes & Findings for Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Combination With Two Corticosteroid Regimens for the Treatment of Lupus Nephritis Flare (NCT NCT00423098)

NCT ID: NCT00423098

Last Updated: 2011-06-28

Results Overview

Complete remission was defined as urine protein/urine creatinine ratio \< 0.5 gram urine protein per gram urine creatinine, urine sediment normalized (no cellular casts, \< 5 red cells per high power field), and serum creatinine within 10% of normal range according to local lab.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 81 participants
• Primary outcome timeframe: 24 Weeks
• Results posted on: 2011-06-28

Participant Flow

Participant milestones

Measure	Standard Dose Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.	Low Dose Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Overall Study STARTED	42	39
Overall Study COMPLETED	39	35
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Measure	Standard Dose Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.	Low Dose Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Overall Study Adverse Event	1	2
Overall Study Unsatisfactory therapeutic effect	0	1
Overall Study Administrative problems	0	1
Overall Study Death	2	0

Baseline Characteristics

Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Combination With Two Corticosteroid Regimens for the Treatment of Lupus Nephritis Flare

Baseline characteristics by cohort

Measure	Standard Dose n=42 Participants Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.	Low Dose n=39 Participants Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.	Total n=81 Participants Total of all reporting groups
Age Continuous	32.2 years STANDARD_DEVIATION 8.53 • n=5 Participants	34.2 years STANDARD_DEVIATION 10.74 • n=7 Participants	33.1 years STANDARD_DEVIATION 9.65 • n=5 Participants
Age, Customized 18-29 years	20 participants n=5 Participants	18 participants n=7 Participants	38 participants n=5 Participants
Age, Customized 30-39 years	16 participants n=5 Participants	10 participants n=7 Participants	26 participants n=5 Participants
Age, Customized 40-49 years	4 participants n=5 Participants	6 participants n=7 Participants	10 participants n=5 Participants
Age, Customized 50-59 years	2 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants
Age, Customized >=60 years	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	29 Participants n=7 Participants	66 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 Weeks

Population: Intention to treat (ITT) population: All randomized patients who received at least one dose of study drug.

Complete remission was defined as urine protein/urine creatinine ratio < 0.5 gram urine protein per gram urine creatinine, urine sediment normalized (no cellular casts, < 5 red cells per high power field), and serum creatinine within 10% of normal range according to local lab.

Outcome measures

Measure	Standard Dose n=42 Participants Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.	Low Dose n=39 Participants Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Number of Patients With Complete Remission Yes	8 Participants	8 Participants
Number of Patients With Complete Remission No	34 Participants	31 Participants

SECONDARY outcome

Timeframe: 12 Weeks

Population: Intention to treat (ITT) population: All randomized patients who received at least one dose of study drug.

Complete remission was defined as urine protein/urine creatinine ratio < 0.5 gram urine protein per gram urine creatinine, urine sediment normalized (no cellular casts, < 5 red cells per high power field), and serum creatinine within 10% of normal value.

Outcome measures

Measure	Standard Dose n=42 Participants Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.	Low Dose n=39 Participants Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Number of Patients With Complete Remission No	33 participants	34 participants
Number of Patients With Complete Remission Yes	9 participants	5 participants

SECONDARY outcome

Timeframe: Baseline to 12 and 24 weeks

Population: Intention to treat (ITT) population: All randomized patients who received at least one dose of study drug.

Partial remission was defined as urine protein/creatinine ratio reduced by at least 50% from baseline and stable serum creatinine within 10% of baseline value) or improved.

Outcome measures

Measure	Standard Dose n=42 Participants Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.	Low Dose n=39 Participants Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Number of Patients With Partial Remission At 12 weeks - Yes	16 Participants	11 Participants
Number of Patients With Partial Remission At 12 weeks - No	26 Participants	28 Participants
Number of Patients With Partial Remission At 24 weeks - Yes	20 Participants	14 Participants
Number of Patients With Partial Remission At 24 weeks - No	22 Participants	25 Participants

SECONDARY outcome

Timeframe: 12 Weeks and 24 Weeks

Population: Intention to treat (ITT) population: All randomized patients who received at least one dose of study drug.

Corticosteroid use was measured as cumulative dose until 12 and 24 weeks of treatment as well as daily doses at baseline, 12 and 24 weeks.

Outcome measures

Measure	Standard Dose n=42 Participants Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.	Low Dose n=39 Participants Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Cumulative Dose of Prednisone Equivalent Corticosteroids (CS) Week 12	106.1 mg/kg Standard Deviation 13.55	68.2 mg/kg Standard Deviation 16.41
Cumulative Dose of Prednisone Equivalent Corticosteroids (CS) Week 24	114.2 mg/kg Standard Deviation 15.01	73.0 mg/kg Standard Deviation 17.76

SECONDARY outcome

Timeframe: 12 and 24 weeks

Population: Intention to treat (ITT) population: All randomized patients who received at least one dose of study drug.

A moderate to severe flare was defined as the occurrence of increased lupus activity after partial or complete remission, based on the presence of 1 BILAG A score or >=3 BILAG B scores. British Isles Lupus Assessment Group (BILAG) index divides lupus activity in 8 organs/systems which are each given a score of A to E. A=disease sufficiently active to need disease modifying treatment; B=problems requiring symptomatic treatment; C=mild stable disease; D=previously affected but currently inactive system; E=the system or organ has never been involved. BILAG score: A=9, B=3, C=1, D/E=0; range(0-72)

Outcome measures

Measure	Standard Dose n=42 Participants Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.	Low Dose n=39 Participants Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Number of Patients With Moderate to Severe Flares At week 12 - Yes	0 participants	0 participants
Number of Patients With Moderate to Severe Flares At week 12 - No	42 participants	39 participants
Number of Patients With Moderate to Severe Flares At week 24 - Yes	1 participants	0 participants
Number of Patients With Moderate to Severe Flares At week 24 - No	41 participants	39 participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Safety population: All patients who received at least one dose of study drug and had at least one post-baseline safety assessment.

The duration of exposure was calculated as the date of the last Mycophenolate sodium dose minus the date of the last Mycophenolate sodium dose +1.

Outcome measures

Measure	Standard Dose n=42 Participants Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.	Low Dose n=39 Participants Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Duration of Exposure to Study Medication	164.5 days Standard Deviation 24.87	157.7 days Standard Deviation 41.15

SECONDARY outcome

Timeframe: 24 weeks

Population: Safety population: All patients who received at least one dose of study drug and had at least one post-baseline safety assessment.

Safety assessments included collecting all adverse events (AEs), serious adverse events (SAEs), with their severity and relationship to study drug. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening ( NIH criteria Grade 4), causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above.

Outcome measures

Measure	Standard Dose n=42 Participants Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.	Low Dose n=39 Participants Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Number of Patients With Adverse Events and Infections Any drug related infection	10 participants	6 participants
Number of Patients With Adverse Events and Infections At least one adverse event	35 participants 5.63	30 participants 6.62
Number of Patients With Adverse Events and Infections Any severe adverse event	7 participants 7.08	3 participants 8.31
Number of Patients With Adverse Events and Infections Any drug related adverse event	18 participants 7.32	16 participants 8.35
Number of Patients With Adverse Events and Infections Any serious adverse event	8 participants	4 participants
Number of Patients With Adverse Events and Infections Any infection	25 participants	17 participants
Number of Patients With Adverse Events and Infections Any severe infection	3 participants	1 participants
Number of Patients With Adverse Events and Infections Any serious infection	4 participants	1 participants

SECONDARY outcome

Timeframe: 12 Weeks and 24 Weeks

Population: Safety Population: All patients who received at least one dose of study drug and had at least one post-baseline safety assessment.

Treatment failure was defined as no therapeutic response (without complete or partial remission) or premature discontinuation during the first 24 weeks from study medication or the study for any reason except complete or partial remission.

Outcome measures

Measure	Standard Dose n=42 Participants Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.	Low Dose n=39 Participants Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Number of Patients With Treatment Failure At 12 weeks - Yes	23 participants	25 participants
Number of Patients With Treatment Failure At 12 weeks - No	19 participants	14 participants
Number of Patients With Treatment Failure At 24 weeks - Yes	21 participants	22 participants
Number of Patients With Treatment Failure At 24 weeks - No	21 participants	17 participants

SECONDARY outcome

Timeframe: From Baseline to week 4, week 12 and week 24

Population: Intent-to-treat (ITT) population included all randomized patients who received at least one dose of study drug. Only patients with assessments at both baseline and post-baseline visits are summarized.

SLEDAI stands for Systemic Lupus Erythematosus Disease Activity Index and was a well established global score index based on assessment of 24 items measuring a disease activity in the 10-day period prior to the assessment. SLEDAI item weights range from 1 for fever to 8 for seizures. A maximum theoretical score is 105. Total score range from 1 to 105. A flare has been defined as a SLEDAI score increase of 3 or more to a level of 8 or higher. During flares SLEDAI scores of 25 to 30 are common.

Outcome measures

Measure	Standard Dose n=42 Participants Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.	Low Dose n=39 Participants Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Change From Baseline in Overall Disease Activity With Systematic Lupus Erythematosus Disease Activity Index (SLEDAI) Change from Baseline to Week 4: (N= 39, 37)	-7.4 Units on a scale Standard Deviation 5.63	-7.7 Units on a scale Standard Deviation 6.62
Change From Baseline in Overall Disease Activity With Systematic Lupus Erythematosus Disease Activity Index (SLEDAI) Change from Baseline to Week 12: (N= 41, 35)	-9.7 Units on a scale Standard Deviation 7.08	-10.3 Units on a scale Standard Deviation 8.31
Change From Baseline in Overall Disease Activity With Systematic Lupus Erythematosus Disease Activity Index (SLEDAI) Change from Baseline to Week 24: (N= 39, 34)	-10.3 Units on a scale Standard Deviation 7.32	-9.8 Units on a scale Standard Deviation 8.35

SECONDARY outcome

Timeframe: From Baseline to week 4, week 12 and week 24

Population: Intent-to-treat (ITT) populationincluded all randomized patients who received at least one dose of study drug. Only patients with assessments at both baseline and post-baseline visits are summarized.

BILAG (British Isles Lupus Assessment Group) index divides lupus activity into 8 organs/systems and was based on the principle of the physician's intention to treat, assessing activity in the previous one month. Each organ or system was given a score of A to E, where A = disease that is sufficiently active to require disease modifying treatment; a B = problems requiring symptomatic treatment; C = stable mild disease; D = previously affected but currently inactive system; and E = the system or organ has never been involved. [A=9, B=3, C=1, D/E=0 the score range for each patient will be 0-72].

Outcome measures

Measure	Standard Dose n=42 Participants Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.	Low Dose n=39 Participants Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Change From Baseline in Overall Disease Activity With British Isles Lupus Assessment Group (BILAG) Change from baseline Week 12: (N= 41, 35)	-8.6 Units on a scale Standard Deviation 6.76	-8.7 Units on a scale Standard Deviation 6.19
Change From Baseline in Overall Disease Activity With British Isles Lupus Assessment Group (BILAG) Change from baseline Week 4: (N= 40, 37)	-4.8 Units on a scale Standard Deviation 5.34	-5.5 Units on a scale Standard Deviation 6.50
Change From Baseline in Overall Disease Activity With British Isles Lupus Assessment Group (BILAG) Change from baseline Week 24: (N= 40, 34)	-8.6 Units on a scale Standard Deviation 5.79	-9.4 Units on a scale Standard Deviation 5.52

Adverse Events

Standard Dose

Serious events: 8 serious events

Other events: 28 other events

Deaths: 0 deaths

Low Dose

Serious events: 4 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Measure	Standard Dose n=42 participants at risk Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.	Low Dose n=39 participants at risk Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Gastrointestinal disorders Diarrhoea	2.4% 1/42	0.00% 0/39
Gastrointestinal disorders Pancreatitis acute	2.4% 1/42	0.00% 0/39
Gastrointestinal disorders Vomiting	2.4% 1/42	0.00% 0/39
General disorders Death	2.4% 1/42	0.00% 0/39
General disorders Mucosal inflammation	2.4% 1/42	0.00% 0/39
General disorders Multi-organ failure	2.4% 1/42	0.00% 0/39
General disorders Oedema peripheral	2.4% 1/42	0.00% 0/39
Infections and infestations Cytomegalovirus infection	2.4% 1/42	0.00% 0/39
Infections and infestations Epstein-barr virus infection	2.4% 1/42	0.00% 0/39
Infections and infestations Gastroenteritis	2.4% 1/42	2.6% 1/39
Infections and infestations Herpes zoster	2.4% 1/42	0.00% 0/39
Infections and infestations Sinusitis	2.4% 1/42	0.00% 0/39
Injury, poisoning and procedural complications Fall	0.00% 0/42	2.6% 1/39
Injury, poisoning and procedural complications Tendon rupture	2.4% 1/42	2.6% 1/39
Nervous system disorders Headache	0.00% 0/42	2.6% 1/39
Nervous system disorders Syncope	0.00% 0/42	2.6% 1/39
Renal and urinary disorders Renal failure acute	2.4% 1/42	0.00% 0/39
Respiratory, thoracic and mediastinal disorders Dysphonia	2.4% 1/42	0.00% 0/39
Vascular disorders Hypertension	2.4% 1/42	2.6% 1/39

Other adverse events

Measure	Standard Dose n=42 participants at risk Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.	Low Dose n=39 participants at risk Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Blood and lymphatic system disorders Anaemia	2.4% 1/42	7.7% 3/39
Cardiac disorders Tachycardia	2.4% 1/42	5.1% 2/39
Gastrointestinal disorders Abdominal pain upper	2.4% 1/42	7.7% 3/39
Gastrointestinal disorders Constipation	7.1% 3/42	2.6% 1/39
Gastrointestinal disorders Diarrhoea	21.4% 9/42	20.5% 8/39
Gastrointestinal disorders Gastritis	0.00% 0/42	5.1% 2/39
Gastrointestinal disorders Nausea	7.1% 3/42	2.6% 1/39
Gastrointestinal disorders Vomiting	7.1% 3/42	10.3% 4/39
General disorders Oedema peripheral	9.5% 4/42	12.8% 5/39
Infections and infestations Folliculitis	0.00% 0/42	5.1% 2/39
Infections and infestations Herpes zoster	14.3% 6/42	0.00% 0/39
Infections and infestations Nasopharyngitis	9.5% 4/42	2.6% 1/39
Infections and infestations Upper respiratory tract infection	9.5% 4/42	5.1% 2/39
Musculoskeletal and connective tissue disorders Arthralgia	9.5% 4/42	12.8% 5/39
Musculoskeletal and connective tissue disorders Muscle spasms	7.1% 3/42	2.6% 1/39
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/42	5.1% 2/39
Psychiatric disorders Insomnia	9.5% 4/42	10.3% 4/39
Respiratory, thoracic and mediastinal disorders Cough	7.1% 3/42	5.1% 2/39
Vascular disorders Hypertension	4.8% 2/42	5.1% 2/39

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER