Ignite Creation Date:
2024-05-06 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 12:46 PM
Study NCT ID:
NCT03541447
Status:
COMPLETED
Last Update Posted:
2022-11-03
First Post:
2018-05-17
Brief Title:
Tolvaptan-Octreotide LAR Combination in ADPKD
Sponsor:
Mario Negri Institute for Pharmacological Research
Organization:
Mario Negri Institute for Pharmacological Research
Study Overview
Official Title:
A Pilot Phase II Study With a Prospective Randomized Cross-Over Placebo-Controlled Double-Blind Design to Assess the Short-Term Effects of Tolvaptan Plus Placebo vs Tolvaptan Plus Octreotide LAR Combination Therapy in ADPKD Patients With Normal Kidney Function or Hyperfiltration
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TOOL
Brief Summary:
Autosomal Dominant Polycystic Kidney Disease ADPKD is a leading cause of End Stage Kidney Disease ESKD worldwide Elevated levels of 3 5 - cyclic AMP cAMP play a central role in the pathogenesis and progression of the disease Vasopressin antagonists and somatostatin analogues which indirectly reduce adenyl cyclase 6 activity have been found to markedly reduce renal tubular cell proliferation and cyst growth in experimental models of ADPKD In combination the two treatments show a clear additive effect and may significantly reduce renal cystic and fibrotic volume as well as cAMP levels to wild type levels
The vasopressin antagonist Tolvaptan and the somatostatin analogue Octreotide share a similar renoprotective effect also in human disease
Both medications effectively slow total kidney and cystic volume TKV and TCV respectively growth and glomerular filtration rate GFR decline in patients with ADPKD The short-term effect of both medications appear to be larger when the GFR is normal or even higher than normal and kidney volumes are still relatively stable On the basis of experimental data it is conceivable that Tolvaptan and Octreotide LAR should have an additive effect also in human disease during initial treatment as well as in the long-term To address the working hypothesis of an additional short-term effect of Tolvaptan and Octreotide we propose to run a pilot explorative randomized placebo-controlled clinical trial with a Cross-Over Design to compare the short-term effects of Tolvaptan monotherapy and Tolvaptan plus Octreotide LAR combination therapy on TKV as assessed by MRI and on GFR as directly measured by the iohexol plasma clearance technique in ADPKD patients with normal 80 to 120 mlmin173m2 kidney function or even kidney hyperfiltration GFR 120 mlmin173m2
The vasopressin antagonist Tolvaptan and the somatostatin analogue Octreotide share a similar renoprotective effect also in human disease
Both medications effectively slow total kidney and cystic volume TKV and TCV respectively growth and glomerular filtration rate GFR decline in patients with ADPKD The short-term effect of both medications appear to be larger when the GFR is normal or even higher than normal and kidney volumes are still relatively stable On the basis of experimental data it is conceivable that Tolvaptan and Octreotide LAR should have an additive effect also in human disease during initial treatment as well as in the long-term To address the working hypothesis of an additional short-term effect of Tolvaptan and Octreotide we propose to run a pilot explorative randomized placebo-controlled clinical trial with a Cross-Over Design to compare the short-term effects of Tolvaptan monotherapy and Tolvaptan plus Octreotide LAR combination therapy on TKV as assessed by MRI and on GFR as directly measured by the iohexol plasma clearance technique in ADPKD patients with normal 80 to 120 mlmin173m2 kidney function or even kidney hyperfiltration GFR 120 mlmin173m2
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-004701-40 | EUDRACT_NUMBER | None | None |