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.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 Am+J+Kidney+Dis
2014 ; 63
(3
): 446-55
Nephropedia Template TP
gab.com Text
Twit Text FOAVip
Twit Text #
English Wikipedia
Rationale and design of the DIPAK 1 study: a randomized controlled clinical trial
assessing the efficacy of lanreotide to Halt disease progression in autosomal
dominant polycystic kidney disease
#MMPMID24342522
Meijer E
; Drenth JP
; d'Agnolo H
; Casteleijn NF
; de Fijter JW
; Gevers TJ
; Kappert P
; Peters DJ
; Salih M
; Soonawala D
; Spithoven EM
; Torres VE
; Visser FW
; Wetzels JF
; Zietse R
; Gansevoort RT
Am J Kidney Dis
2014[Mar]; 63
(3
): 446-55
PMID24342522
show ga
BACKGROUND: There are limited therapeutic options to slow the progression of
autosomal dominant polycystic kidney disease (ADPKD). Recent clinical studies
indicate that somatostatin analogues are promising for treating polycystic liver
disease and potentially also for the kidney phenotype. We report on the design of
the DIPAK 1 (Developing Interventions to Halt Progression of ADPKD 1) Study,
which will examine the efficacy of the somatostatin analogue lanreotide on
preservation of kidney function in ADPKD. STUDY DESIGN: The DIPAK 1 Study is an
investigator-driven, randomized, multicenter, controlled, clinical trial. SETTING
& PARTICIPANTS: We plan to enroll 300 individuals with ADPKD and estimated
glomerular filtration rate (eGFR) of 30-60 mL/min/1.73 m(2) who are aged 18-60
years. INTERVENTION: Patients will be randomly assigned (1:1) to standard care or
lanreotide, 120 mg, subcutaneously every 28 days for 120 weeks, in addition to
standard care. OUTCOMES: Main study outcome is the slope through serial eGFR
measurements starting at week 12 until end of treatment for lanreotide versus
standard care. Secondary outcome parameters include change in eGFR from
pretreatment versus 12 weeks after treatment cessation, change in kidney volume,
change in liver volume, and change in quality of life. MEASUREMENTS: Blood and
urine will be collected and questionnaires will be filled in following a fixed
scheme. Magnetic resonance imaging will be performed for assessment of kidney and
liver volume. RESULTS: Assuming an average change in eGFR of 5.2 ± 4.3 (SD)
mL/min/1.73 m(2) per year in untreated patients, 150 patients are needed in each
group to detect a 30% reduction in the rate of kidney function loss between
treatment groups with 80% power, 2-sided ? = 0.05, and 20% protocol violators
and/or dropouts. LIMITATIONS: The design is an open randomized controlled trial
and measurement of our primary end point does not begin at randomization.
CONCLUSIONS: The DIPAK 1 Study will show whether subcutaneous administration of
lanreotide every 4 weeks attenuates disease progression in patients with ADPKD.
|Adolescent
[MESH]
|Adult
[MESH]
|Antineoplastic Agents/administration & dosage/therapeutic use
[MESH]
|Disease Progression
[MESH]
|Dose-Response Relationship, Drug
[MESH]
|Female
[MESH]
|Follow-Up Studies
[MESH]
|Glomerular Filtration Rate/*drug effects
[MESH]
|Humans
[MESH]
|Injections, Subcutaneous
[MESH]
|Male
[MESH]
|Middle Aged
[MESH]
|Peptides, Cyclic/administration & dosage/*therapeutic use
[MESH]