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Steroids in the Maintenance of Remission of Proliferative Lupus Nephritis (SIMPL)

Primary Purpose

Lupus Nephritis

Status
Withdrawn
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
prednisolone
Placebo
Sponsored by
Cambridge University Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Nephritis focused on measuring systemic lupus erythematosus, lupus nephritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Addenbrooke's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

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

Outcomes

Primary Outcome Measures

Feasibility (recruitment rate and protocol adherence)

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

Full Information

First Posted
October 4, 2007
Last Updated
May 28, 2008
Sponsor
Cambridge University Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00539799
Brief Title
Steroids in the Maintenance of Remission of Proliferative Lupus Nephritis
Acronym
SIMPL
Official Title
Corticosteroids in the Maintenance Therapy of Proliferative Lupus Nephritis: a Randomized Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Withdrawn
Why Stopped
Local pharmacy unwilling to comply with study protocol
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Cambridge University Hospitals NHS Foundation Trust

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis
Keywords
systemic lupus erythematosus, lupus nephritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Long-term low-dose prednisolone (5 - 7.5 mg/day)
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
prednisolone
Intervention Description
5 - 7.5 mg/day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matched placebo to prednisolone
Primary Outcome Measure Information:
Title
Feasibility (recruitment rate and protocol adherence)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
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
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Jayne, MD
Organizational Affiliation
Cambridge University Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Walsh, MD
Organizational Affiliation
Cambridge University Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Addenbrooke's Hospital
City
Cambridge
State/Province
Cambridgeshire
Country
United Kingdom

12. IPD Sharing Statement

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Steroids in the Maintenance of Remission of Proliferative Lupus Nephritis

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