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

This study is currently recruiting participants.
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

March 15, 2012
February 12, 2014
April 2012
June 2017   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01560052 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Therapeutic Evaluation of Steroids in IgA Nephropathy Global Study (TESTING Study)
Therapeutic Evaluation of Steroids in IgA Nephropathy Global Study

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

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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
IgA Glomerulonephritis
  • 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
  • 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.
  • 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.
    Intervention: Drug: methylprednisolone
  • Placebo Comparator: placebo
    Matching placebo ; Optimal blood pressure control and full dose of ACE inhibitors or ARBs as recommended by guidelines.
    Intervention: Drug: Placebo,
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1300
September 2017
June 2017   (final data collection date for primary outcome measure)

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 -
Both
14 Years and older
No
Contact: Vlado Perkovic +61299934500 vperkovic@george.org.au
Australia,   China
 
NCT01560052
GI-R-01-2011
Yes
The George Institute
The George Institute
Peking University First Hospital
Principal Investigator: Haiyan Wang Renal Division, Peking University First Hospital
Principal Investigator: Vlado Perkovic The George Institute
The George Institute
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP