Comparison of short course cyclophosphamide followed by mycophenolate mofetil versus long course cyclophosphamide in the treatment of proliferative lupus nephritis.

Second Dutch Lupus Nephritis trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29290

Enrollment

124

Registered

2005-10-07

Start date

2003-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with SLE and biopsy proven proliferative lupus nephritis

Interventions

Cyclophosphamide, mycophenolate, prednisone.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18 - 70 yrs; 2. SLE (presence of at least 4 ACR-criteria for SLE; 3. Proliferative lupus nephritis: a. Biopsy proven lupus nephritis WHO class III or IV (according to Churg 1995). and b. “Active sediment”. > 5 ery’s per HPF and/or celcylinders and c. Proteïnuria > 0.5 g/day; 4. Adequate anticonception; 5. Informed consent.

Exclusion criteria

Exclusion criteria: 1. Active infection; 2. Pregnancy; 3. Known allergy for one of the study drugs; 4. Malignancy < 5 years prior to inclusion.

Design outcomes

Primary

Measure	Time frame
Number of renal relapses.	—

Secondary

Measure	Time frame
1. Longitudinal follow-up of creatinine, proteïnuria, sediment, complement levels, anti-dsDNA, SLEDAI, SLICC, Dutch lupus nephritis questionaire, SF-36, renal histology, IF-skin; 2. Extra-renale exacerbaties van de SLE; 3. Zwangerschap; 4. Overlijden.	—

Contacts

Public ContactMarc Bijl

University Medical Center Groningen (UMCG), Department of Clinical Immunology, P.O. Box 30.001

m.bijl@int.umcg.nl+31 (0)50 3612945

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)