SIMPL: Steroids in the Maintenance of Remission of Proliferative Lupus Nephritis

Sponsor

Cambridge University Hospitals NHS Foundation Trust (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00539799

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

There is debate as to whether long-term low-dose steroids such as prednisolone help to suppress relapses of systemic lupus erythematosus (SLE) in patients who are in remission from their lupus nephritis. If low-dose prednisolone reduces relapses, these beneficial effects may be counter-balanced by the long-term side-effects associated with prednisolone. This pilot study will determine the feasibility of conducting a larger randomized control trial that will answer the question of whether or not long-term low-dose prednisolone (5 - 7.5 mg/day) reduces the flares of SLE in patients with previous lupus nephritis.

Condition or Disease	Intervention/Treatment	Phase
Lupus Nephritis	Drug: prednisolone Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Corticosteroids in the Maintenance Therapy of Proliferative Lupus Nephritis: a Randomized Pilot Study

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Long-term low-dose prednisolone (5 - 7.5 mg/day)	Drug: prednisolone 5 - 7.5 mg/day
Placebo Comparator: 2	Drug: Placebo Matched placebo to prednisolone

Arm

Intervention/Treatment

Active Comparator: 1

Long-term low-dose prednisolone (5 - 7.5 mg/day)

Drug: prednisolone

5 - 7.5 mg/day

Placebo Comparator: 2

Drug: Placebo

Matched placebo to prednisolone

Outcome Measures

Primary Outcome Measures

Feasibility (recruitment rate and protocol adherence) [12 months]

Secondary Outcome Measures

1) time to major renal and non-renal relapses of SLE 2) time to minor relapses of SLE 3) health related quality of life 4) adverse events/side-effects 5) accrual of SLE related organ damage 6) renal function [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

age at least 18 years
diagnosis of SLE by ACR criteria
diagnosis of proliferative lupus nephritis (ISN/RPS class III or IV)
currently on prednisolone (5 to 20 mg/day)
in partial or complete remission for at least 3 months

Exclusion Criteria:

currently pregnant
in end-stage renal failure
receiving corticosteroids for an indication other than lupus nephritis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Addenbrooke's Hospital	Cambridge	Cambridgeshire	United Kingdom

Sponsors and Collaborators

Cambridge University Hospitals NHS Foundation Trust

Investigators

Principal Investigator: David Jayne, MD, Cambridge University Hospitals NHS Foundation Trust
Principal Investigator: Michael Walsh, MD, Cambridge University Hospitals NHS Foundation Trust