Study of the Safety, Tolerability, and Pharmacokinetics of LHW090 in Patients With Moderately Impaired Renal Function

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Kidney Disease (CKD)

In brief

This was a randomized, double-blind, parallel group, placebo-controlled study, in two sequential parts that evaluated the renal safety, tolerability and pharmacokinetics of LHW090 in patients with moderately impaired renal function.

Key facts

Study ID

NCT02678000

Run by

Novartis Pharmaceuticals

People needed

84

Starts

2017-03-10

Expected to finish

2018-10-11

Last updated by the study team

2021-10-06

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• History of angioedema, drug-related or otherwise, as reported by the patient.
• Use of angiotensin converting enzyme inhibitors (ACE inhibitors), mineralocorticoid receptor antagonists (e.g. spironolactone or eplerenone), aliskiren, vasopressin receptor antagonists (e.g. tolvaptan), or oral alkalinizing agents (e.g. sodium and potassium citrate or Shohl's solution). Note: Patients who discontinue their ACE-inhibitor and substitute with an angiotensin receptor blocker (ARB) may be eligible to be rescreened provided their medication regimen has been stable for at least 1 month and their renal function has been stable for at least 3 months. Any substitutions or changes to a patient's medication regimen must be done under the guidance of the patient's treating physician.
• History of a renal transplant.
• Known current significant left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy or significant severe valvular disease on prior or current echocardiogram.
• A serum potassium ≤ 3.5 mmol/l or ≥ 5.2 mmol/l at screening.
• A previous history or previously diagnosed renal cystic disease such as autosomal dominant polycystic kidney disease (history of an incidental asymptomatic acquired renal cyst(s) is excepted); obstructive uropathy; renal stone(s) in the past 2 years; chronic interstitial nephropathy; drug induced nephropathy; residual renal insufficiency following an episode of acute kidney injury or acute tubular necrosis related to renal atheroembolic disease, septic shock or ischemic nephropathy; renal tubular acidosis requiring treatment; nephrotic syndrome or nephrotic range proteinuria; or renal artery stenosis.

Where it is running

• Novartis Investigative Site — Anaheim, California, United States
• Novartis Investigative Site — Lakewood, Colorado, United States
• Novartis Investigative Site — Miami Lakes, Florida, United States
• Novartis Investigative Site — Orlando, Florida, United States
• Novartis Investigative Site — New Orleans, Louisiana, United States
• Novartis Investigative Site — Minneapolis, Minnesota, United States
• Novartis Investigative Site — Saint Paul, Minnesota, United States
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Elsterwerda, Germany
• Novartis Investigative Site — Erlangen, Germany
• Novartis Investigative Site — Hamburg, Germany
• Novartis Investigative Site — Mannheim, Germany

Full record on ClinicalTrials.gov

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