A randomized trial comparing cyclosporine versus azathioprine for maintenance therapy in diffuse lupus nephritis
| ISRCTN | ISRCTN34265870 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34265870 |
| Protocol serial number | NEO-I-22 |
| Sponsor | Novartis Farma (Italy) |
| Funder | The study was sponsored by Novartis and monitored by an external society. The steering committee approved the study protocol, case report forms, statistical analysis plan, progress of the study and analysis, as well as the reporting of the data, whatever the outcome of the study. The sponsors could comment on the manuscript before submission, but the final version was the sole responsibility of the authors. In addition, the steering committee had full access to the data files of the study. |
- Submission date
- 07/07/2004
- Registration date
- 22/11/2004
- Last edited
- 11/02/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Claudio Ponticelli
Scientific
Scientific
via Ampere 126
Milano
20131
Italy
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Lupus nephritis |
| Intervention | Administration of 3 intravenous methylprednisolone pulses followed by a 2-3 month treatment with prednisone and oral cyclophosphamide. Patients with serum creatinine ≤1.5 mg/dl, proteinuria ≥0.5 g per day and diastolic blood pressure <90 mmHg were then randomized to receive cyclosporine or azathioprine for two years. |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 75 |
| Key inclusion criteria | Seventy five patients presenting with diffuse proliferative lupus nephritis |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2000 |
| Date of final enrolment | 31/12/2004 |
Locations
Countries of recruitment
- Italy
Study participating centre
via Ampere 126
Milano
20131
Italy
20131
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2006 | Yes | No |
