Therapeutic Evaluation of Steroids in IgA Nephropathy Global Study (TESTING Study)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by The George Institute
Sponsor:
Collaborator:
Peking University First Hospital
Information provided by (Responsible Party):
The George Institute
ClinicalTrials.gov Identifier:
NCT01560052
First received: March 15, 2012
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

This study will evaluate the long-term efficacy and safety of oral methylprednisolone on a background of routine RAS inhibitor therapy, in preventing kidney events in patients with IgA nephropathy and features suggesting a high risk of progression


Condition Intervention
IgA Glomerulonephritis
Drug: methylprednisolone
Drug: Placebo,

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: Therapeutic Evaluation of Steroids in IgA Nephropathy Global Study

Resource links provided by NLM:


Further study details as provided by The George Institute:

Primary Outcome Measures:
  • Progressive kidney failure [ Time Frame: 1-6 years ] [ Designated as safety issue: No ]
    Progressive kidney failure, which is a composite of a 50% decrease in eGFR, the development of end stage kidney disease defined as a need for maintenance dialysis or kidney transplantation, and death due to kidney disease.


Secondary Outcome Measures:
  • The composite of ESKD, 50% decrease in eGFR and all cause death [ Time Frame: 1-6 years ] [ Designated as safety issue: No ]
  • Each of ESKD, renal death and all cause death [ Time Frame: 1-6 years ] [ Designated as safety issue: No ]
  • Proteinuria remission [ Time Frame: 1-6 years ] [ Designated as safety issue: No ]
  • Annual eGFR decline rate [ Time Frame: 1-6 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1300
Study Start Date: April 2012
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: oral methylprednisolone
methylprednisolone group; start at 0.8mg/kg/day with a maximal 48mg/day×2 months, taper by 8mg/day every month to stop within 6-8 months; Optimal blood pressure control and full dose of ACE inhibitors or ARBs as recommended by guidelines.
Drug: methylprednisolone
oral methylprednisolone or placebo 0.8mg/kg/day with a maximum 48mg/day x 2 months, taper by 8mg/day every month to stop within 6-8 months. All the patients will also receive optimal blood pressure control and full dose of ACE inhibitors or ARBs as recommended by guidelines throughout the trial.
Other Name: Medrol
Placebo Comparator: placebo
Matching placebo ; Optimal blood pressure control and full dose of ACE inhibitors or ARBs as recommended by guidelines.
Drug: Placebo,
Matching placebo tablets; All the patients will also receive optimal blood pressure control and full dose of ACE inhibitors or ARBs as recommended by guidelines throughout the trial.

Detailed Description:

Study outcomes

  • Primary outcome Progressive kidney failure, which is a composite of a 50% decrease in eGFR, the development of end stage kidney disease defined as a need for maintenance dialysis or kidney transplantation, and death due to kidney disease
  • Secondary outcomes The composite of ESKD, 50% decrease in eGFR and all cause death; Each of ESKD, renal death and all cause death; Annual eGFR decline rate; Proteinuria remission
  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. IgA nephropathy proven on renal biopsy within the previous 2 years yet can extend to 3 years
  2. Proteinuria: >1.0g/day while receiving maximum tolerated dose of RAS blockade following the recommended treatment guidelines of each country where the trial is conducted.
  3. eGFR: 20 to 70ml/min per 1.73m²

Exclusion Criteria:

  1. Indication for immunosuppressive therapy with corticosteroids, such as:

    • Minimal change renal disease with IgA deposits
    • Crescents present in >50% of glomeruli on a renal biopsy within the last 12 months.
  2. Contraindication to immunosuppressive therapy with corticosteroids, including

    • Active infection, including HBV infection or clinical evidence of latent or active tuberculosis (nodules, cavities, tuberculoma, etc)
    • Malignancy within the last 5 years, excluding treated non-melanoma skin cancers (ie. squamous or basal cell carcinoma)
    • Current or planned pregnancy or breastfeeding
    • Women of childbearing age who are not able or willing to use adequate contraception
  3. Systemic immunosuppressive therapy in the previous year.
  4. Malignant /uncontrolled hypertension (>160mm systolic or 110mmHg diastolic)
  5. Unstable kidney function for other reasons, e.g. macrohaematuria induced acute kidney injury
  6. Age <14 years old
  7. Secondary IgA nephropathy: e.g. due to lupus, liver cirrhosis, Henoch-Schonlein purpura
  8. Patients who are unlikely to comply with the study protocol in the view of the treating physician -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01560052

Contacts
Contact: Vlado Perkovic +61299934500 vperkovic@george.org.au

  Show 46 Study Locations
Sponsors and Collaborators
The George Institute
Peking University First Hospital
Investigators
Principal Investigator: Haiyan Wang Renal Division, Peking University First Hospital
Principal Investigator: Vlado Perkovic The George Institute
  More Information

No publications provided

Responsible Party: The George Institute
ClinicalTrials.gov Identifier: NCT01560052     History of Changes
Other Study ID Numbers: GI-R-01-2011
Study First Received: March 15, 2012
Last Updated: February 12, 2014
Health Authority: China: Ethics Committee

Keywords provided by The George Institute:
end stage kidney disease
IgA nephropathy

Additional relevant MeSH terms:
Glomerulonephritis
Glomerulonephritis, IGA
Kidney Diseases
Nephritis
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Angiotensin-Converting Enzyme Inhibitors
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids

ClinicalTrials.gov processed this record on July 26, 2014