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

This study has been withdrawn prior to enrollment.
(Local pharmacy unwilling to comply with study protocol)
Information provided by:
Cambridge University Hospitals NHS Foundation Trust Identifier:
First received: October 4, 2007
Last updated: May 28, 2008
Last verified: May 2008
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 Intervention Phase
Lupus Nephritis
Drug: prednisolone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Corticosteroids in the Maintenance Therapy of Proliferative Lupus Nephritis: a Randomized Pilot Study

Resource links provided by NLM:

Further study details as provided by Cambridge University Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Feasibility (recruitment rate and protocol adherence) [ Time Frame: 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 [ Time Frame: 24 months ]

Estimated Enrollment: 15
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00539799

United Kingdom
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
Principal Investigator: David Jayne, MD Cambridge University Hospitals NHS Foundation Trust
Principal Investigator: Michael Walsh, MD Cambridge University Hospitals NHS Foundation Trust
  More Information Identifier: NCT00539799     History of Changes
Other Study ID Numbers: A091040  EUDRACT: 2007-003923-20 
Study First Received: October 4, 2007
Last Updated: May 28, 2008
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Cambridge University Hospitals NHS Foundation Trust:
systemic lupus erythematosus
lupus nephritis

Additional relevant MeSH terms:
Lupus Nephritis
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Kidney Diseases
Lupus Erythematosus, Systemic
Urologic Diseases
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Protective Agents processed this record on May 24, 2016