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Rationale and design of the RESOLVE trial: lanreotide as a volume reducing treatment for polycystic livers in patients with autosomal dominant polycystic kidney disease.

Gevers TJ, Chrispijn M, Wetzels JF, Drenth JP - BMC Nephrol (2012)

Bottom Line: Symptoms arise when liver volume increases.The somatostatin analogue lanreotide has proven to reduce liver volume in patients with polycystic liver disease.However, this study also included patients with isolated polycystic liver disease (PCLD).

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Gastroenterology and Hepatology, Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands.

ABSTRACT

Background: A large proportion of patients with autosomal dominant polycystic kidney disease (ADPKD) suffers from polycystic liver disease. Symptoms arise when liver volume increases. The somatostatin analogue lanreotide has proven to reduce liver volume in patients with polycystic liver disease. However, this study also included patients with isolated polycystic liver disease (PCLD). The RESOLVE trial aims to assess the efficacy of lanreotide treatment in ADPKD patients with symptomatic polycystic livers. In this study we present the design of the RESOLVE trial.

Methods/design: This open-label clinical trial evaluates the effect of 6 months of lanreotide in ADPKD patients with symptomatic polycystic livers. Primary outcome is change in liver volume determined by computerised tomography-volumetry. Secondary outcomes are changes in total kidney volume, kidney intermediate volume and renal function. Furthermore, urinary (NGAL, α1-microglobulin, KIM-1, H-FABP, MCP-1) and serum (fibroblast growth factor 23) biomarkers associated with ADPKD disease severity are assessed to investigate whether these biomarkers predict treatment responses to lanreotide. Moreover, safety and tolerability of the drug in ADPKD patients will be assessed.

Discussion: We anticipate that lanreotide is an effective therapeutic option for ADPKD patients with symptomatic polycystic livers and that this trial aids in the identification of patient related factors that predict treatment response.

Trial registration number: Clinical trials.gov NCT01354405.

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Related in: MedlinePlus

RESOLVE trial profile. ADPDK subjects are screened for eligibility, and 43 ADPKD patients with symptomatic polycystic liver disease and eGFR > 30 ml/min (MDRD formula) will be included. At day 1, all patients undergo CT volumetry of liver and kidneys. Patients without polycystic type II or III livers, as determined with CT volumetry, will be excluded from the study. Interval visits are scheduled 4 and 12 weeks after start of treatment. After 24 weeks of treatment with lanreotide (6 injections), another CT will be performed to evaluate the change in liver and kidney volume.
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Figure 1: RESOLVE trial profile. ADPDK subjects are screened for eligibility, and 43 ADPKD patients with symptomatic polycystic liver disease and eGFR > 30 ml/min (MDRD formula) will be included. At day 1, all patients undergo CT volumetry of liver and kidneys. Patients without polycystic type II or III livers, as determined with CT volumetry, will be excluded from the study. Interval visits are scheduled 4 and 12 weeks after start of treatment. After 24 weeks of treatment with lanreotide (6 injections), another CT will be performed to evaluate the change in liver and kidney volume.

Mentions: The primary objective of the RESOLVE trial is to determine the effectiveness of lanreotide to attenuate growth of liver volume in ADPKD patients with symptomatic polycystic livers. ADPKD patients with polycystic livers will receive lanreotide 120 mg every 4 weeks for a total of 24 weeks (Figure 1). Secondary objectives are to assess the effect of lanreotide treatment on total kidney and kidney intermediate volume, to follow renal function and to identify biomarkers that predict treatment response. Finally, safety and tolerability of lanreotide treatment in ADPKD patients will also be assessed.


Rationale and design of the RESOLVE trial: lanreotide as a volume reducing treatment for polycystic livers in patients with autosomal dominant polycystic kidney disease.

Gevers TJ, Chrispijn M, Wetzels JF, Drenth JP - BMC Nephrol (2012)

RESOLVE trial profile. ADPDK subjects are screened for eligibility, and 43 ADPKD patients with symptomatic polycystic liver disease and eGFR > 30 ml/min (MDRD formula) will be included. At day 1, all patients undergo CT volumetry of liver and kidneys. Patients without polycystic type II or III livers, as determined with CT volumetry, will be excluded from the study. Interval visits are scheduled 4 and 12 weeks after start of treatment. After 24 weeks of treatment with lanreotide (6 injections), another CT will be performed to evaluate the change in liver and kidney volume.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3368739&req=5

Figure 1: RESOLVE trial profile. ADPDK subjects are screened for eligibility, and 43 ADPKD patients with symptomatic polycystic liver disease and eGFR > 30 ml/min (MDRD formula) will be included. At day 1, all patients undergo CT volumetry of liver and kidneys. Patients without polycystic type II or III livers, as determined with CT volumetry, will be excluded from the study. Interval visits are scheduled 4 and 12 weeks after start of treatment. After 24 weeks of treatment with lanreotide (6 injections), another CT will be performed to evaluate the change in liver and kidney volume.
Mentions: The primary objective of the RESOLVE trial is to determine the effectiveness of lanreotide to attenuate growth of liver volume in ADPKD patients with symptomatic polycystic livers. ADPKD patients with polycystic livers will receive lanreotide 120 mg every 4 weeks for a total of 24 weeks (Figure 1). Secondary objectives are to assess the effect of lanreotide treatment on total kidney and kidney intermediate volume, to follow renal function and to identify biomarkers that predict treatment response. Finally, safety and tolerability of lanreotide treatment in ADPKD patients will also be assessed.

Bottom Line: Symptoms arise when liver volume increases.The somatostatin analogue lanreotide has proven to reduce liver volume in patients with polycystic liver disease.However, this study also included patients with isolated polycystic liver disease (PCLD).

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Gastroenterology and Hepatology, Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands.

ABSTRACT

Background: A large proportion of patients with autosomal dominant polycystic kidney disease (ADPKD) suffers from polycystic liver disease. Symptoms arise when liver volume increases. The somatostatin analogue lanreotide has proven to reduce liver volume in patients with polycystic liver disease. However, this study also included patients with isolated polycystic liver disease (PCLD). The RESOLVE trial aims to assess the efficacy of lanreotide treatment in ADPKD patients with symptomatic polycystic livers. In this study we present the design of the RESOLVE trial.

Methods/design: This open-label clinical trial evaluates the effect of 6 months of lanreotide in ADPKD patients with symptomatic polycystic livers. Primary outcome is change in liver volume determined by computerised tomography-volumetry. Secondary outcomes are changes in total kidney volume, kidney intermediate volume and renal function. Furthermore, urinary (NGAL, α1-microglobulin, KIM-1, H-FABP, MCP-1) and serum (fibroblast growth factor 23) biomarkers associated with ADPKD disease severity are assessed to investigate whether these biomarkers predict treatment responses to lanreotide. Moreover, safety and tolerability of the drug in ADPKD patients will be assessed.

Discussion: We anticipate that lanreotide is an effective therapeutic option for ADPKD patients with symptomatic polycystic livers and that this trial aids in the identification of patient related factors that predict treatment response.

Trial registration number: Clinical trials.gov NCT01354405.

Show MeSH
Related in: MedlinePlus