| Study name |
Estudio piloto aleatorizado comparativo de tacrolimus vs ciclofosfamida‐prednisona en la nefropatía membranosa idiopática ‐ MEMTAC |
| Methods |
Study design: parallel RCT Study duration: not reported Duration of follow‐up: 18 months Sample size: 40 planned |
| Participants |
Country: Spain Setting: not reported Inclusion criteria: PMN; both sexes; ≥ 18 years; diagnosed by renal biopsy, of IMN proteinuria in the nephrotic range (> 3.5 g/24 hours) with hypoalbuminaemia (serum albumin ≤ 25 to 30 g/dL) sustained for at least 6 months; kidney function with SCr <1.3 mg/dL and CrCl > 60 mL/min according to the Cockroft‐Gault formula; taking ACEi and/or ARA II for at least 6 months before the start of the study; written informed consent Exclusion criteria: pregnant or breast‐feeding or of childbearing age who do not use medically suitable methods of contraception (barrier methods) and who do not have a negative pregnancy test; diabetic; secondary glomerulonephritis (drugs, systemic diseases, tumours); received previous treatments with immunosuppressants in the previous 6 months; neoplasia or history of cancer; serious systemic infection; histologically proven liver cirrhosis or significant elevation of liver enzymes; HIV or for the surface antigen of hepatitis B or for the antibodies of the Hepatitis C virus; addiction or abuse of drugs, medications or alcohol; psychiatric alterations or condition that could invalidate the communication between the researcher and the patient; life expectancy diminished for any reason, so that they cannot complete the study |
| Interventions |
Group1
Group 2
|
| Outcomes |
Complete and partial remission Complete remission: proteinuria < 0.3 g/day, with GFR > 60 mL/min/1.73 m² and albuminaemia ≤ 30 g/L Partial remission: reduction > 50% of basal proteinuria, the last being < 3.5 g/day; with GFR > 60 mL/min/1.73 m² and albuminaemia ≤ 30 g/L Kidney function: SCr and CrCl at 6, 12 and 18 months Nephrotic time: time to complete remission/partial remission Recurrence: in the subpopulation of patients who have reached a remission of the disease, it will be determined until the end of the study in each patient whether or not they have a nephrotic proteinuria |
| Starting date |
11/06/2008 |
| Contact information |
Spain |
| Notes |
None |
