Table 4

Interventions in the pulse versus continuous CPA studies

Study ID

Treatment

Control

Study outcomes


Adu 1997

CPA 15 mg/kg and MP were given IV at 0, 2

and 4 weeks. The same dose was then given

as oral pulses over a 3-day period.

The interval between pulses was gradually increased.

initial treatment - 0.85 mg/kg prednisolone

then tapering according to a predefined

schedule for 72 weeks.

CPA 2 mg/kg/d given until a clinical decision

that remission had been achieved at which

point CPA was stopped and AZA commenced

at 1.5 mg/kg/d

1. Complete and partial remission

2. Relapse

3. Adverse events

4. Treatment failure

5. Chronic dialysis

De Groot

2009a

3 iv pulses of CPA 15 mg/kg 2 weeks apart

followed by 3 weekly pulses (15 mg/kg iv or

5 mg/kg orally for 3 days) until remission then

for another 3 months.

Mac dose 1.2 G.

Reductions for age > 60 yrs and serum

creatinine > 300 uM and for previous

low leukocyte nadir.

oral CPA 2 mg/kg/d to remission then 1.5 mg/kg

for further 3 months. Max oral dose 200 mg.

Reductions for age > 60 yrs and leukopenia

Both groups received Azathioprine 2 mg/kg/d

orally after induction therapy until month 18.

Prednisolone 1 mg/kg orally tapered to 12.5 mg/d

at the end of month3 and 5 mg at end of study

1. Time to Remission

2. Change in renal function

3. Adverse events

4. Cumulative dose of CPA

Guillevin

1997

Initial regimen: IV MP 15 mg/kg/d for 3 days.

IV CPA 0.7 g/m2 day 4.

Oral prednisolone 1 mg/kg/d from day 4.

IV pulse CPA: mean dose 0.7 g/m2 adjusted for

count and renal function, administered every

3 weeks until complete remission and 1 year thereafter.

Then every 4 weeks for 4 months, every 5 weeks for 4 months and every 6 weeks until

discontinuation after 2 years if treatment.

Adjusted up or down based on neutrophil count.

Initial regimen: IV MP 15 mg/kg/d for 3 days.

IV CPA 0.7 g/m2 day 4.

Oral prednisolone 1 mg/kg/d from day 4.

Oral CPA: 2 mg/kg/d on day 10 after initial CPA

pulse, after neutrophil nadir had been reached.

1 year after complete remission, oral CPA was

tapered by 25% every 4 months until discontinuation.

Dose adjusted up or down based on neutrophil count.

1. Treatment failure

2. Complete remission

3. Partial remission

4. Relapse

5. Death

6. Side effects

Haubitz

1998

Steroid regime: Days 1-3, 0.5 g IV MP.

Day 4 1 mg/kg/d oral prednisolone.

Tapered from day 15.

IV Pulse CPA - 0.75 g/m2 every 4th week.

If CrCl < 30 ml/min, initial dosage was 0.5 g/m2

and increased to 0.75 g/m2 provided leukocyte

counts remained > 3000/ml

Steroid regime: Days 1-3, 0.5 g IV MP.

Day 4 1 mg/kg/d oral prednisolone.

Tapered from day 15. Oral daily CPA

- 2 mg/kg/d. If CrCl < 30 ml/min,

initial dosage started at 1.5 mg/kg/d and increase

to 2 mg/kg/d after 2 weeks provided leukocyte

counts were > 3000/ml CPA dose reduced in steps

of 0.5 mg/kg, unless leukocyte count was

< 2500/ml then dose reduced by 50%, and if

less than 1500/ml drug was withheld

until increased to 2500/ml

1. Complete remission

2. Partial remission

3. Relapse

4. Serious infection


Walters et al. BMC Nephrology 2010 11:12   doi:10.1186/1471-2369-11-12

Open Data