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Trial record 44 of 117 for:    "Connective Tissue Disease" | "Methylprednisolone"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00539799
Recruitment Status : Withdrawn (Local pharmacy unwilling to comply with study protocol)
First Posted : October 5, 2007
Last Update Posted : May 29, 2008
Information provided by:
Cambridge University Hospitals NHS Foundation Trust

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Feasibility (recruitment rate and protocol adherence) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00539799

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United Kingdom
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
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Principal Investigator: David Jayne, MD Cambridge University Hospitals NHS Foundation Trust
Principal Investigator: Michael Walsh, MD Cambridge University Hospitals NHS Foundation Trust

Layout table for additonal information Identifier: NCT00539799     History of Changes
Other Study ID Numbers: A091040
EUDRACT: 2007-003923-20
First Posted: October 5, 2007    Key Record Dates
Last Update Posted: May 29, 2008
Last Verified: May 2008

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

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