Evaluator conclusion The study included a small number of patients with short duration of treatment. There was no evidence of significant difference in efficacy in the defined terms which is not to say that significant difference has been ruled out. Statistical approach was neither superiority nor non-inferiority in design begging the question, was the approach decided post-hoc. The inclusion of the word superiority in the title is considered misleading. Li et al. 2011 MMF vs. tacrolimus vs. IVC - Jadad score 1 – Methods Country: Setting: Not specified design: Randomised controlled trial Blinding: No ITT: Yes Participants 60 patients aged between 16 64 years in three groups of 20 – participants 87% female. Classes III, IV, V or combination and chronic index 3 with urinary ≤ protein excretion g/24 h and/or a recent deterioration in renal ≥1.0 function. Interventions MMF: 1.5g 2g/day – Tacrolimus: 0.08 01 mg/kg/day – IVC: 0.5 0.75 g/m2/ month – Prednisolone 0.8 1 mg/kg/day to max 60 mg reducing to minimum – 10 mg/day over 4 months Outcomes Assessed at 24 Primary outcome: Complete remission or partial remission Complete remission: Urinary protein excretion < 0.3 g/24 h, with normal urine sediment, serum albumin concentration of > 35 g/L and stabilization (15%) or improvement in serum creatinine at 24 weeks. Partial remission: Urinary protein excretion between 0.3 and 2.9 g/24h, having decreased by from baseline values, with ≥50% serum albumin concentration g/L and stabilization (30%) in ≥30 serum creatinine. Notes Imbalance of baseline demographics noted with MMF group including patients with lower median age, lower median serum creatinine, higher creatinine clearance and higher serum albumen. Random sequence No details generation (selection bias)
Evaluator conclusion The study included a small number of patients with short duration of treatment. There was no evidence of significant difference in efficacy in the defined terms which is not to say that significant difference has been ruled out. Statistical approach was neither superiority nor non-inferiority in design begging the question, was the approach decided post-hoc. The inclusion of the word superiority in the title is considered misleading. Li et al. 2011 – MMF vs. tacrolimus vs. IVC - Jadad score 1 Methods Country: Setting: Not specified design: Randomised controlled trial Blinding: No ITT: Yes Participants 60 patients aged between 16 – 64 years in three groups of 20 participants 87% female. Classes III, IV, V or combination and chronic index ≤ 3 with urinary protein excretion ≥1.0 g/24 h and/or a recent deterioration in renal function. Interventions MMF: 1.5g – 2g/day Tacrolimus: 0.08 – 01 mg/kg/day IVC: 0.5 – 0.75 g/m2/ month Prednisolone 0.8 – 1 mg/kg/day to max 60 mg reducing to minimum 10 mg/day over 4 months Outcomes Assessed at 24 Primary outcome: Complete remission or partial remission Complete remission: Urinary protein excretion < 0.3 g/24 h, with normal urine sediment, serum albumin concentration of > 35 g/L and stabilization (15%) or improvement in serum creatinine at 24 weeks. Partial remission: Urinary protein excretion between 0.3 and 2.9 g/24h, having decreased by ≥50% from baseline values, with serum albumin concentration ≥30 g/L and stabilization (30%) in serum creatinine. Notes Imbalance of baseline demographics noted with MMF group including patients with lower median age, lower median serum creatinine, higher creatinine clearance and higher serum albumen. Random sequence generation (selection bias) No details
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