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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This study has been withdrawn prior to enrollment.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)
Sponsor:
Information provided by:
Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00539799
First received: October 4, 2007
Last updated: May 28, 2008
Last verified: May 2008
History of Changes
  Purpose

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:

MedlinePlus related topics: Lupus
U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00539799

Locations
United Kingdom
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
  More Information

No publications provided

ClinicalTrials.gov 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
Nephritis
Glomerulonephritis
Kidney Diseases
Urologic Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
 Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on June 18, 2013