Condition category
Musculoskeletal Diseases
Date applied
07/07/2004
Date assigned
22/11/2004
Last edited
11/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Claudio Ponticelli

ORCID ID

Contact details

via Ampere 126
Milano
20131
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NEO-I-22

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2000

Overall trial end date

31/12/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Seventy five patients presenting with diffuse proliferative lupus nephritis

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

75

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2000

Recruitment end date

31/12/2004

Locations

Countries of recruitment

Italy

Trial participating centre

via Ampere 126
Milano
20131
Italy

Sponsor information

Organisation

Novartis Farma (Italy)

Sponsor details

Largo U. Boccioni 1
Origgio
21040
Italy
+39 (0)2 9654 2351
simona.greco@pharma.novartis.com

Sponsor type

Industry

Website

http://www.novartis.com/

Funders

Funder type

Industry

Funder name

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.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2006 results on http://www.ncbi.nlm.nih.gov/pubmed/17699309

Publication citations

  1. Results

    Moroni G, Doria A, Mosca M, Alberighi OD, Ferraccioli G, Todesco S, Manno C, Altieri P, Ferrara R, Greco S, Ponticelli C, A randomized pilot trial comparing cyclosporine and azathioprine for maintenance therapy in diffuse lupus nephritis over four years., Clin J Am Soc Nephrol, 2006, 1, 5, 925-932, doi: 10.2215/CJN.02271205.

Additional files

Editorial Notes