Longterm Renal Oucomes of STOP-IgAN Trial Participants

NCT03488368 | Completed

• 1 other identifier: STOP IgAN - Longterm
• Study Type: observational
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

IgA nephropathy (IgAN) is the most prevalent form of primary glomerulonephritis in the Western world. Although most IgAN patients take a benign longterm course, about 20-30% progress to end-stage renal disease (ESRD) over 20 years. The majority of current treatment recommendations is based on weak evidence. In the randomized, controlled Supportive Versus Immunosuppressive Therapy for the Treatment Of Progressive IgAN (STOP-IgAN) trial, the investigators analyzed whether additional immunosuppression on top of standardized supportive care provides renal benefits in patients with progressive IgAN. Patients with persisting proteinuria \>0.75 g/d (n=162) despite optimized supportive treatment including control of blood pressure and proteinuria, were randomized to either continue on supportive care or to receive additional immunosuppression during the 3-year trial phase. It was observed that immunosuppressive therapy in addition to optimized supportive care led to more full clinical remissions, but eventually did not better preserve renal function, did not better save patients from ESRD development and evoked more adverse effects such as infections, weight gain and diabetes. Aim of this planned study is to analyze renal outcome measures and adverse effects in the longterm observation of all randomized STOP-IgAN participants to ascertain quality and strength of the original trial results. By its observational nature, this quality control study includes the 162 IgAN patients (with the exception of drop-out patients) that had been previously randomized into the original STOP-IgAN trial. Information on serum creatinine, proteinuria, ESRD, death, relevant adverse events such as major cardiovascular events, osteoporosis, osteonecrosis, bone fractures, diabetes, malignancies and interim treatment will be collected as available from existing routine records until March 31, 2018. Primary endpoint is the time to the first occurring event of the binary composite of all-cause death, ESRD or decline in estimated glomerular filtration rate (eGFR) by at least 40% as compared to enrollment into the original trial. Secondary outcome measures comprise the individual components of the primary endpoint, absolute eGFR at the end of observation, proteinuria and adverse events. Information on specific treatments with renin-angiotensin-system (RAS)-blocking agents and/or interim immunosuppression will also be collected. All data will be recorded in a pseudonymous fashion in a central electronic data base located at the PI's site.

Conditions

IgA Nephropathy

Outcome Measures

Primary Outcomes (1)

• Time to the first occurring event of the binary composite of all-cause death, end-stage renal disease (ESRD) and of estimated glomerular filtration rate (eGFR)-loss >40% based on available data by March 31, 2018.

  Time to the first occurring event of the binary composite of all-cause death, end-stage renal disease (ESRD) and of estimated glomerular filtration rate (eGFR)-loss \>40% based on available data by March 31, 2018. For GFR-loss, we consider eGFR values baseline (enrolment into original STOP-IgAN trial) and the last two available values by March 31, 2018. For GFR-loss, eGFR will be calculated using the creatinine-based, formula of Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi). Data will be considered at baseline, 6 months, 12 months, 24 months and 36 months after randomization and the last two available values by March 31, 2018.

  as available by March 31, 2018

Secondary Outcomes (6)

• all-cause death

  as available by March 31, 2018

• end-stage renal disease (ESRD)

  as available by March 31, 2018

• first occurrence of eGFR-loss > 40%

  as available by March 31, 2018

• first occurrence of eGFR-loss > 30%

  as available by March 31, 2018

• course of proteinuria

  as available by March 31, 2018

Study Arms (2)

Supportive-care group

Observation of IgAN patients who received supportive care measures (without additional immunosuppression) during the first three years after randomization, i.e. trial phase of the original STOP-IgAN trial.

Other: observation

Immunosuppression group

Observation of IgAN patients who received supportive care measures and additional immunosuppression during the first three years after randomization, i.e. trial phase of the original STOP-IgAN trial.

Other: observation

Interventions

observation OTHER

Observation of renal outcome parameters and adverse events in the follow-up beyond the 3-year trial phase of the original STOP-IgAN trial.

Immunosuppression group; Supportive-care group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All randomized STOP-IgAN participants with the exception of drop-outs.

You may qualify if:

• All randomized STOP-IgAN participants.

You may not qualify if:

• Drop-outs of the main STOP-IgAN trial.

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

Medical Clinic II, University Hospital Aachen

Aachen, Germany

Location

Related Publications (1)

• Rauen T, Eitner F, Fitzner C, Sommerer C, Zeier M, Otte B, Panzer U, Peters H, Benck U, Mertens PR, Kuhlmann U, Witzke O, Gross O, Vielhauer V, Mann JF, Hilgers RD, Floege J; STOP-IgAN Investigators. Intensive Supportive Care plus Immunosuppression in IgA Nephropathy. N Engl J Med. 2015 Dec 3;373(23):2225-36. doi: 10.1056/NEJMoa1415463.

  PMID: 26630142 RESULT

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

Observation

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Juergen Floege, MD

  RWTH Aachen University, University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Jürgen Floege

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: April 5, 2018
• Study Start: February 1, 2018
• Primary Completion: July 31, 2018
• Study Completion: December 31, 2018
• Last Updated: March 26, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)