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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT00539799
First Posted: October 5, 2007
Last Update Posted: May 29, 2008
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.
Information provided by:
Cambridge University Hospitals NHS Foundation Trust
  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
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 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00539799     History of Changes
Other Study ID Numbers: A091040
EUDRACT: 2007-003923-20
First Submitted: October 4, 2007
First Posted: October 5, 2007
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:
Nephritis
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Prednisolone acetate
Methylprednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents