ADPKD
IMPEDE
Metformin vs Placebo for patients with ADPKD
Inclusion Criteria
- eGFR >45
- Can be on tolvaptan
HD
ACHEIVE
Spiro vs Placebo in patients on HD
Inclusion Criteria
- on HD or PD >= 3/12
- >45 yo
- >18 if DM
- Exluded if K+ >5.8
GN - LUPUS
ALXN 1210
A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study
to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants
With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy
completed (IgAN)
- Ravulizumab is a humanized monoclonal antibody
which inhibits complement component 5
- Similar to eculizumab but much longer acting
- PBS approved for PNH
- There is substantial interest in the role of complement pathway in
lupus nephritis
Inclusion Criteria
- Age between 18 and 75
- Body weight >40kg
- Must be vaccinated or agree to be vaccinated against Meningococcal
infection, Haemophilus influenza type b and Streptococcus pneumoniae
prior to randomization.
- Participants on SGLT-2 inhibitors must be on a stable dose 12 weeks
prior to screening
- Kidney biopsy diagnosed class III or class IV LN within 6mths of
screening or during screening
- Clinical diagnosis of SLE
- Proteinuria with UPCR ≥ 1g/g
GN - FSGS
AFFINITY
A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with
Proteinuric Glomerular Diseases
The Phase 2 AFFINITY study will assess the efficacy and safety of
atrasentan in patients with proteinuric glomerular diseases at risk of
progressive kidney function loss.
Cohort 2 – FSGS
Inclusion Criteria
- Biopsy confirmed FSGS
- UPCR>1.5g/g
- eGFR ≥ 30mL/min/1.73m2
- Receiving RAS inhibitor stable for 12 weeks pre screening
- If receiving systemic corticosteriods or calcineurin inhibitors,
dose must be stable for 12 weeks pre screening
- BMI < 40 Kg/m2
BI 1434
A multicentre, randomized, double-blind, parallel group, placebo
controlled study to assess safety, tolerability, pharmacokinetics and
pharmacodynamics of BI 764198 administered orally once daily for 12
weeks in patients with focal segmental glomerulosclerosis.
BI 764198 is a potent inhibitor of human TRPC6
Inclusion Criteria
- 18 – 75 and able to sign Informed Consent
- Biopsy Proven FSGS or documented TRPC6 mutation
- UPCR ≥ 1000mg/g
- Completion of initial corticosteroid therapy (if applicable).
- Patients treated with corticosteroids must be on a stable dose for
at least 4 weeks prior to
- screening visit with no plan to change the dose until end of trial
treatment.
- Pt’s treated with ACE inhibitors, ARBs, finerenone, aldosterone
inhibitors, or SGLT2 inhibitors should be on a stable dose for >4
weeks before screening visit with no plan to change the dose until the
end of trial treatment.
GN - NEPHROTIC SYN
APAXANS
This study will evaluate primarily the pharmacokinetics and safety
and efficacy of apixaban as a preventative for venous thromboembolism in
patients with nephrotic syndrome as compared to warfarin
Inclusion Criteria
- All adult patients with nephrotic syndrome with serum albumin
<25g/L (for prevention of nephrotic syndrome related thrombotic
disease)
- Minimum age: 18 years /Maximum age: No Limit/Gender: both male and
female
Exclusion Criteria
- eGFR of less than 25mL/min /Patients requiring any form of
dialysis
- Abnormal liver dysfunction {defined as chronic Liver Disease
(Child-Pugh score of B or C cirrhosis) or biochemical evidence of
significant hepatic derangement (bilirubin 2-3 times the upper limit of
normal, in association with aspartate transaminase (AST) or alkaline
phosphatase (ALP) levels 3 times the upper limit normal).}
- Known hereditary or acquired bleeding disorders
- Antiphospholipid syndrome
- Haemoglobin (Hb) <90g/L/ Platelets <100,000/ul
GN - ANCA
ANCA Relapse
Inclusion Criteria
Existing and new patients with confirmed ANCA + ve vasculitis
attending follow-up for ongoing monitoring
Registries
Three registries are ongoing.
- QRBR – Inclusion criteria: patients undergoing renal biopsy
- aHUS Registry- Inclusion criteria- Patients diagnosed to have aHUS
(received/receiving Eculizumab)
- AUSLUPUS Registry- Inclusion criteria – Patients diagnosed to have
SLE/Lupus Nephritis
Previous Trials recruited in KHS
Data collected from 2023 onwards
FALCON
Bardoxylone vs Placebo for patients with ADPKD
Recruitment stopped Q1 2023
AFFINITY
A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with
Proteinuric Glomerular Diseases
Alports population recruitment stopped Q1 2023
PHOSPHATE
Phosphate targets of <= 1.5 vs 2-2.5 in patients on HD
Recruitment target met Q2 2023
ALIGN
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of
Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss
of Renal Function
Recruitment finished Q2 2023